<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04493398</url>
  </required_header>
  <id_info>
    <org_study_id>2016/793</org_study_id>
    <nct_id>NCT04493398</nct_id>
  </id_info>
  <brief_title>Air-polishing or Conventional Treatment</brief_title>
  <official_title>Erythritol Air-polishing Versus Curette/Ultrasonic Debridement of Mandibular Furcation Lesions in Supportive Periodontal Therapy A 12-Month Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bergen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: To effectively disrupt microbial biofilm and remove dental calculus with minimal&#xD;
      damage to the root surface and soft tissues with limited patient discomfort constitute a&#xD;
      significant tenet of periodontal therapy. The aim of the present prospective 12-month study&#xD;
      was to compare clinical and microbiological effects following an erythritol air-polishing vs.&#xD;
      conventional mechanical debridement of furcation defects in a cohort of periodontal&#xD;
      maintenance patients.&#xD;
&#xD;
      Methods: Twenty patients with grade II mandibular molar furcation defects volunteered to&#xD;
      enroll in this study. In a split-mouth design, two furcation sites in each patient were&#xD;
      randomly assigned to either receive subgingival debridement using erythritol air-polishing&#xD;
      (test) or conventional ultrasonic/curette debridement (control) at baseline, and at 3, 6, 9&#xD;
      and 12 months. Probing depth, clinical attachment level and bleeding on probing were recorded&#xD;
      at 3-month intervals. Subgingival microbiological samples obtained at baseline, 6 and 12&#xD;
      months were analyzed using checkerboard DNA-DNA hybridization. Discomfort from treatment was&#xD;
      scored at 12 months using a visual analogue scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION.Traditionally, periodontal debridement is accomplished using curettes, sonic or&#xD;
      ultrasonic scalers, all presenting comparable outcomes.1,2 However, periodic root&#xD;
      instrumentation may lead to dental hard tissue3-6 and soft tissue damage,7 and sensitivity&#xD;
      due to exposure of dentinal tubules.8-10 Air-polishing using low abrasive glycine or&#xD;
      trehalose powder has been shown to reach similar clinical outcomes as hand and ultrasonic&#xD;
      instrumentation, but with less hard tissue loss.11-16 Moreover, air-polishing provides&#xD;
      superior outcomes relative to patient comfort and time efficiency.7,11,12,14 Recently, a low&#xD;
      abrasive erythritol powder with comparable physical properties to glycine air-polishing&#xD;
      powder was introduced for subgingival air-polishing.17 Erythritol, a non-toxic, chemically&#xD;
      neutral and completely water-soluble polyol is widely used in food industry as an artificial&#xD;
      sweetener. Two studies comparing conventional mechanical debridement with erythritol&#xD;
      air-polishing, reported similar results in supportive periodontal therapy (SPT) relative to&#xD;
      clinical and microbiological outcomes.18,19 Such observations are also reflected in a&#xD;
      systematic review concluding that air-polishing systems as a monotherapy are comparable to&#xD;
      conventional therapy in patients undergoing SPT in single- and multi-rooted teeth without&#xD;
      furcations.20 Moreover, inhibitory effects on pathogenic bacteria including Porphyromonas&#xD;
      gingivalis have also been observed.21 To the investigator's knowledge, no prospective studies&#xD;
      investigating the efficacy of a low abrasive erythritol air-polishing system in molar&#xD;
      furcation defects during SPT have been reported. The objective of this 12-month prospective&#xD;
      study was to compare clinical and microbiological effects following an erythritol&#xD;
      air-polishing system vs. conventional mechanical debridement of furcation defects in a cohort&#xD;
      of periodontal maintenance patients.&#xD;
&#xD;
      METHOD AND MATERIALS. The study protocol and informed consent following the Helsinki&#xD;
      Declaration of 1975 (version 2008) was approved by the Medical Research Ethics Committee&#xD;
      (2016/793), University of Bergen, Norway. Participating subjects read and signed the informed&#xD;
      consent prior to enrolling in the study.&#xD;
&#xD;
      Prestudy calibration and training. Two operators performed the clinical aspects of this&#xD;
      study. Author TS, masked to treatment assignments, performed all clinical recordings and&#xD;
      sampling, author IU performed all treatments.&#xD;
&#xD;
      Sample size. The sample size estimation was based on change in PD. A difference of 0.5 mm was&#xD;
      considered clinically relevant.22 Standard deviation of the difference between repeated PD&#xD;
      measurements from the intra-calibration exercise was 0.5 mm. A power analysis based on 20&#xD;
      subjects and with the level of significance (α) set to 0.05, resulted in 98.9% power to&#xD;
      detect a true difference of 0.5 mm.&#xD;
&#xD;
      Treatments. Following baseline examination, mandibular jaw quadrants were randomized (coin&#xD;
      toss) to either receive debridement using the erythritol powder/air-polishing system (test)&#xD;
      or conventional ultrasonic/curette instrumentation (control) using a split-mouth study&#xD;
      design. Sequence of treatments was randomized in a similar fashion. Treatments were delivered&#xD;
      at baseline, and repeated at 3, 6, 9 and 12 months. Test sites thus received root debridement&#xD;
      using the low abrasive erythritol powder (Air-flow powder plus®, EMS, Nyon, Switzerland )&#xD;
      applied through a Perio-Flow hand piece connected to an airflow unit (Air-Flow Master®, EMS,&#xD;
      Nyon, Switzerland). The hand piece was fitted with a nozzle for subgingival delivery&#xD;
      directing the power/air jet perpendicular to the root surface at the water exit at the tip of&#xD;
      the nozzle. The nozzle was inserted to the apical aspect of furcation sites with PD≥ 4 mm&#xD;
      using striking movements over the furcation area for 5 sec.12 Sites adjoining the test site&#xD;
      with PD≥ 4 mm were similarly treated.&#xD;
&#xD;
      Control sites were debrided using an ultrasonic scaler (Piezon Master 400 Perio Slim Tip®;&#xD;
      Electro Medical System, Nyon, Switzerland) with power set at 75% and water as coolant, and&#xD;
      root planed with sharp curettes (Gracey SAS, Hu-Friedy, Chicago, IL, USA).&#xD;
&#xD;
      Patients were returned to their regular SPT upon completion of study. Gingival crevicular&#xD;
      fluid assessments. Gingival crevicular fluid (GCF) was recorded at baseline, and at 6 and 12&#xD;
      months. Briefly, furcation sites were isolated with cottons rolls, cleaned for supragingival&#xD;
      plaque, and air-dried. A perio paper strip was then placed 1-2 mm into the orifice of the&#xD;
      site and left in place for 30 sec. Next, the perio strip was inserted into the Periotron&#xD;
      8000® (Oraflow, Smithtown, NY, USA) calibrated to estimate the volume of GCF collected.&#xD;
&#xD;
      Microbiological assessments. At baseline, and at 6 and 12 months the supragingival area above&#xD;
      the furcation site was wiped clean using sterile cotton pellets. Three sterile paper points&#xD;
      were then inserted into the pocket of the furcation site. The paper points were kept in place&#xD;
      20 sec27 removed and immersed into pre-reduced, anaerobic transport medium (PRAS; Dental&#xD;
      Transport Medium, Morgan Hill, CA, USA).&#xD;
&#xD;
      Pain experience assessments. Visual analogue scale (VAS) scores were used to estimate patient&#xD;
      discomfort experienced during test and control treatment.31 Scoring was performed at 12&#xD;
      months following completion of the debridement with 0=&quot;no pain&quot; and 100=&quot;worst pain I can&#xD;
      imagine&quot;.&#xD;
&#xD;
      Statistical analysis Data were entered into MS-Excel (Microsoft, Redmond, WA, USA ) proofed&#xD;
      for errors and then imported into Stata, version 15 (StataCorp, College Station, TX, USA).&#xD;
&#xD;
      Summary statistics (means ± SEM) for the clinical variables were calculated for the test and&#xD;
      control at baseline, and at 6 and 12 months. Due to the repeated nature of data, a mixed&#xD;
      effect model taking into consideration incomplete data at 12 months was applied to analyze&#xD;
      the data at patient and tooth level. Time and treatment were considered fixed factors. Mixed&#xD;
      models were applied for both primary and secondary outcome variables.&#xD;
&#xD;
      For testing differences in microbial composition at test and control sites harboring&#xD;
      different proportions of bacteria &gt;105 at baseline, and at 6 and 12 months, logistic&#xD;
      regression models with robust standard error were applied. VAS scores were analyzed using&#xD;
      ordinary linear regression models with robust standard error. The level of significance was&#xD;
      set at 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2015</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized, single-masked controlled trial (RCT). A split-mouth study design where each of the furcation in the lower jaw molars was randomized to the two specific treatments. Hence, each patient received both interventions randomly allocated to each side of the lower jaw.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Two operators performed the clinical aspects of this study. Author TS, masked to treatment assignments, performed all clinical recordings and sampling, author IU performed all treatments. All analyses were performed by a statistician (SAL) who had not taken part in data collection or treatments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>In 20 patients with grade II mandibular molar furcation defects, probing depth (PD) will be measured.</measure>
    <time_frame>12 months.</time_frame>
    <description>PD: The vertical distance from the gingival margin to the probable base of the pocket in mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In 20 patients with grade II mandibular molar furcation defects clinical attachment level (CAL) will be measured.</measure>
    <time_frame>12 months.</time_frame>
    <description>CAL: The vertical distance in mm from the cemento-enamel junction or the margin of a dental restoration to the probable base of the pocket.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing (BoP).</measure>
    <time_frame>12 months.</time_frame>
    <description>At site level, BoP was recorded as present upon gentle probing to the base of the vertical furcation pocket.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival crevicular fluid (GCF).</measure>
    <time_frame>12 months.</time_frame>
    <description>Twenty test and control sites were isolated with cottons rolls, cleaned for supragingival plaque, and air-dried. A perio paper strip was then placed 1-2 mm into the orifice of the site and left in place for 30 sec. The perio strip was inserted into the Periotron 8000® (Oraflow, Smithtown, NY, USA) calibrated to estimate the volume of GCF collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS).</measure>
    <time_frame>12 months.</time_frame>
    <description>VAS scores were used to estimate patient discomfort experienced during test and control treatment by drawing a vertical line on a 100-millimeter standardized horizontal line (0=&quot;no pain&quot; and 100=&quot;worst pain I can imagine&quot;).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Periodontitis</condition>
  <condition>Adult Periodontitis</condition>
  <arm_group>
    <arm_group_label>Titanium curette and ultrasonic.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Debridement of mandibular furcations with conventional ultrasonic/curette (control).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erythritol air-polishing.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment of mandibular furcations with erythritol powder/air-polishing system (test)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gracey curette.</intervention_name>
    <description>Root planed was performed with curettes (Gracey SAS, Hu-Friedy, Chicago, IL, USA).</description>
    <arm_group_label>Titanium curette and ultrasonic.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasonic scaler.</intervention_name>
    <description>Debridement was performed with an ultrasonic scaler (Piezon Master 400 Perio Slim Tip®; Electro Medical System, Nyon, Switzerland).</description>
    <arm_group_label>Titanium curette and ultrasonic.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erythritol air-polishing.</intervention_name>
    <description>Treatment was performed with a low abrasive erythritol powder (Air-flow powder plus®, EMS, Nyon, Switzerland ) applied through a Perio-Flow hand piece connected to an airflow unit (Air-Flow Master®, EMS, Nyon, Switzerland).</description>
    <arm_group_label>Erythritol air-polishing.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Received supportive periodontal therapy (SPT) every 3-6 months for 2-3 years following&#xD;
             periodontal therapy.&#xD;
&#xD;
          2. Having bilateral non-mobile, fully erupted mandibular first, second or third molars&#xD;
             with degree II furcation defects.&#xD;
&#xD;
          3. PD≥4 mm with bleeding or pus on probing. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mobile mandibular molars, molars with clinical or radiographic evidence of&#xD;
             supra-/subgingival calculus or apical pathology.&#xD;
&#xD;
          2. Use of systemic antibiotics within 6 months or SPT within 3 months of study.&#xD;
&#xD;
          3. Any current medical condition affecting periodontal treatment or use of the abrasive&#xD;
             air-polishing device.&#xD;
&#xD;
          4. Subjects with diabetes, cancer, HIV/aids, acute infections, disorders that may&#xD;
             compromise wound healing, or pregnant women.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Knut N. Leknes, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY.</affiliation>
  </overall_official>
  <reference>
    <citation>Wilson TG Jr. Supportive periodontal treatment introduction--definition, extent of need, therapeutic objectives, frequency and efficacy. Periodontol 2000. 1996 Oct;12:11-5. doi: 10.1111/j.1600-0757.1996.tb00074.x. No abstract available.</citation>
    <PMID>9567987</PMID>
  </reference>
  <reference>
    <citation>Badersten A, Nilveus R, Egelberg J. Effect of nonsurgical periodontal therapy. II. Severely advanced periodontitis. J Clin Periodontol. 1984 Jan;11(1):63-76. doi: 10.1111/j.1600-051x.1984.tb01309.x.</citation>
    <PMID>6363463</PMID>
  </reference>
  <reference>
    <citation>Zappa U, Smith B, Simona C, Graf H, Case D, Kim W. Root substance removal by scaling and root planing. J Periodontol. 1991 Dec;62(12):750-4. doi: 10.1902/jop.1991.62.12.750.</citation>
    <PMID>1765938</PMID>
  </reference>
  <reference>
    <citation>Flemmig TF, Petersilka GJ, Mehl A, Hickel R, Klaiber B. Working parameters of a magnetostrictive ultrasonic scaler influencing root substance removal in vitro. J Periodontol. 1998 May;69(5):547-53. doi: 10.1902/jop.1998.69.5.547.</citation>
    <PMID>9623897</PMID>
  </reference>
  <reference>
    <citation>Lie T, Leknes KN. Evaluation of the effect on root surfaces of air turbine scalers and ultrasonic instrumentation. J Periodontol. 1985 Sep;56(9):522-31. doi: 10.1902/jop.1985.56.9.522.</citation>
    <PMID>3897504</PMID>
  </reference>
  <reference>
    <citation>Schmidlin PR, Beuchat M, Busslinger A, Lehmann B, Lutz F. Tooth substance loss resulting from mechanical, sonic and ultrasonic root instrumentation assessed by liquid scintillation. J Clin Periodontol. 2001 Nov;28(11):1058-66. doi: 10.1034/j.1600-051x.2001.281111.x.</citation>
    <PMID>11686828</PMID>
  </reference>
  <reference>
    <citation>Petersilka GJ. Subgingival air-polishing in the treatment of periodontal biofilm infections. Periodontol 2000. 2011 Feb;55(1):124-42. doi: 10.1111/j.1600-0757.2010.00342.x. No abstract available.</citation>
    <PMID>21134232</PMID>
  </reference>
  <reference>
    <citation>Fischer C, Wennberg A, Fischer RG, Attstrom R. Clinical evaluation of pulp and dentine sensitivity after supragingival and subgingival scaling. Endod Dent Traumatol. 1991 Dec;7(6):259-65. doi: 10.1111/j.1600-9657.1991.tb00214.x.</citation>
    <PMID>1820859</PMID>
  </reference>
  <reference>
    <citation>Latheef P, Sirajuddin S, Gundapaneni V, Mn K, Apine A. Iatrogenic Damage to the Periodontium Caused by Periodontal Treatment Procedures. Open Dent J. 2015 Jun 26;9:203-7. doi: 10.2174/1874210601509010203. eCollection 2015.</citation>
    <PMID>26312087</PMID>
  </reference>
  <reference>
    <citation>Lin YH, Gillam DG. The Prevalence of Root Sensitivity following Periodontal Therapy: A Systematic Review. Int J Dent. 2012;2012:407023. doi: 10.1155/2012/407023. Epub 2012 Oct 31.</citation>
    <PMID>23193405</PMID>
  </reference>
  <reference>
    <citation>Petersilka GJ, Steinmann D, Haberlein I, Heinecke A, Flemmig TF. Subgingival plaque removal in buccal and lingual sites using a novel low abrasive air-polishing powder. J Clin Periodontol. 2003 Apr;30(4):328-33. doi: 10.1034/j.1600-051x.2003.00290.x.</citation>
    <PMID>12694431</PMID>
  </reference>
  <reference>
    <citation>Petersilka G. Re: &quot;Subgingival plaque removal using a new air-polishing device&quot;. Moene R, Decaillet F, Andersen E, Mombelli A. (J Periodontol 2010;81:79-88.). J Periodontol. 2010 Jul;81(7):962-3. doi: 10.1902/jop.2010.100118. No abstract available.</citation>
    <PMID>20553116</PMID>
  </reference>
  <reference>
    <citation>Flemmig TF, Arushanov D, Daubert D, Rothen M, Mueller G, Leroux BG. Randomized controlled trial assessing efficacy and safety of glycine powder air polishing in moderate-to-deep periodontal pockets. J Periodontol. 2012 Apr;83(4):444-52. doi: 10.1902/jop.2011.110367. Epub 2011 Aug 23.</citation>
    <PMID>21861637</PMID>
  </reference>
  <reference>
    <citation>Wennstrom JL, Dahlen G, Ramberg P. Subgingival debridement of periodontal pockets by air polishing in comparison with ultrasonic instrumentation during maintenance therapy. J Clin Periodontol. 2011 Sep;38(9):820-7. doi: 10.1111/j.1600-051X.2011.01751.x. Epub 2011 Jul 7.</citation>
    <PMID>21736599</PMID>
  </reference>
  <reference>
    <citation>Caygur A, Albaba MR, Berberoglu A, Yilmaz HG. Efficacy of glycine powder air-polishing combined with scaling and root planing in the treatment of periodontitis and halitosis: A randomised clinical study. J Int Med Res. 2017 Jun;45(3):1168-1174. doi: 10.1177/0300060517705540. Epub 2017 Apr 20.</citation>
    <PMID>28425827</PMID>
  </reference>
  <reference>
    <citation>Kruse AB, Akakpo DL, Maamar R, Woelber JP, Al-Ahmad A, Vach K, Ratka-Krueger P. Trehalose powder for subgingival air-polishing during periodontal maintenance therapy: A randomized controlled trial. J Periodontol. 2019 Mar;90(3):263-270. doi: 10.1002/JPER.17-0403. Epub 2018 Nov 9.</citation>
    <PMID>30311948</PMID>
  </reference>
  <reference>
    <citation>Hagi TT, Hofmanner P, Salvi GE, Ramseier CA, Sculean A. Clinical outcomes following subgingival application of a novel erythritol powder by means of air polishing in supportive periodontal therapy: a randomized, controlled clinical study. Quintessence Int. 2013 Nov-Dec;44(10):753-61. doi: 10.3290/j.qi.a30606.</citation>
    <PMID>24078975</PMID>
  </reference>
  <reference>
    <citation>Hagi TT, Hofmanner P, Eick S, Donnet M, Salvi GE, Sculean A, Ramseier CA. The effects of erythritol air-polishing powder on microbiologic and clinical outcomes during supportive periodontal therapy: Six-month results of a randomized controlled clinical trial. Quintessence Int. 2015 Jan;46(1):31-41. doi: 10.3290/j.qi.a32817.</citation>
    <PMID>25262675</PMID>
  </reference>
  <reference>
    <citation>Muller N, Moene R, Cancela JA, Mombelli A. Subgingival air-polishing with erythritol during periodontal maintenance: randomized clinical trial of twelve months. J Clin Periodontol. 2014 Sep;41(9):883-9. doi: 10.1111/jcpe.12289. Epub 2014 Aug 7.</citation>
    <PMID>25041441</PMID>
  </reference>
  <reference>
    <citation>Ng E, Byun R, Spahr A, Divnic-Resnik T. The efficacy of air polishing devices in supportive periodontal therapy: A systematic review and meta-analysis. Quintessence Int. 2018;49(6):453-467. doi: 10.3290/j.qi.a40341.</citation>
    <PMID>29700503</PMID>
  </reference>
  <reference>
    <citation>Hashino E, Kuboniwa M, Alghamdi SA, Yamaguchi M, Yamamoto R, Cho H, Amano A. Erythritol alters microstructure and metabolomic profiles of biofilm composed of Streptococcus gordonii and Porphyromonas gingivalis. Mol Oral Microbiol. 2013 Dec;28(6):435-51. doi: 10.1111/omi.12037. Epub 2013 Jul 29.</citation>
    <PMID>23890177</PMID>
  </reference>
  <reference>
    <citation>Bunaes DF, Lie SA, Enersen M, Aastrom AN, Mustafa K, Leknes KN. Site-specific treatment outcome in smokers following non-surgical and surgical periodontal therapy. J Clin Periodontol. 2015 Oct;42(10):933-42. doi: 10.1111/jcpe.12462. Epub 2015 Oct 28.</citation>
    <PMID>26407817</PMID>
  </reference>
  <reference>
    <citation>Muhlemann HR, Son S. Gingival sulcus bleeding--a leading symptom in initial gingivitis. Helv Odontol Acta. 1971 Oct;15(2):107-13. No abstract available.</citation>
    <PMID>5315729</PMID>
  </reference>
  <reference>
    <citation>O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.</citation>
    <PMID>4500182</PMID>
  </reference>
  <reference>
    <citation>Hamp SE, Nyman S, Lindhe J. Periodontal treatment of multirooted teeth. Results after 5 years. J Clin Periodontol. 1975 Aug;2(3):126-35. doi: 10.1111/j.1600-051x.1975.tb01734.x.</citation>
    <PMID>1058213</PMID>
  </reference>
  <reference>
    <citation>Barros SP, Williams R, Offenbacher S, Morelli T. Gingival crevicular fluid as a source of biomarkers for periodontitis. Periodontol 2000. 2016 Feb;70(1):53-64. doi: 10.1111/prd.12107.</citation>
    <PMID>26662482</PMID>
  </reference>
  <reference>
    <citation>Belibasakis GN, Schmidlin PR, Sahrmann P. Molecular microbiological evaluation of subgingival biofilm sampling by paper point and curette. APMIS. 2014 Apr;122(4):347-52. doi: 10.1111/apm.12151. Epub 2013 Jul 24.</citation>
    <PMID>23879704</PMID>
  </reference>
  <reference>
    <citation>Socransky SS, Haffajee AD, Smith C, Martin L, Haffajee JA, Uzel NG, Goodson JM. Use of checkerboard DNA-DNA hybridization to study complex microbial ecosystems. Oral Microbiol Immunol. 2004 Dec;19(6):352-62. doi: 10.1111/j.1399-302x.2004.00168.x.</citation>
    <PMID>15491460</PMID>
  </reference>
  <reference>
    <citation>Socransky SS, Smith C, Martin L, Paster BJ, Dewhirst FE, Levin AE. &quot;Checkerboard&quot; DNA-DNA hybridization. Biotechniques. 1994 Oct;17(4):788-92.</citation>
    <PMID>7833043</PMID>
  </reference>
  <reference>
    <citation>Socransky SS, Haffajee AD, Cugini MA, Smith C, Kent RL Jr. Microbial complexes in subgingival plaque. J Clin Periodontol. 1998 Feb;25(2):134-44. doi: 10.1111/j.1600-051x.1998.tb02419.x.</citation>
    <PMID>9495612</PMID>
  </reference>
  <reference>
    <citation>Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.</citation>
    <PMID>2197679</PMID>
  </reference>
  <reference>
    <citation>Krohn-Dale I, Boe OE, Enersen M, Leknes KN. Er:YAG laser in the treatment of periodontal sites with recurring chronic inflammation: a 12-month randomized, controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):745-52. doi: 10.1111/j.1600-051X.2012.01912.x. Epub 2012 Jun 13.</citation>
    <PMID>22694321</PMID>
  </reference>
  <reference>
    <citation>Hujoel PP, Loesche WJ. Efficiency of split-mouth designs. J Clin Periodontol. 1990 Nov;17(10):722-8. doi: 10.1111/j.1600-051x.1990.tb01060.x.</citation>
    <PMID>2262586</PMID>
  </reference>
  <reference>
    <citation>Hujoel PP, DeRouen TA. Validity issues in split-mouth trials. J Clin Periodontol. 1992 Oct;19(9 Pt 1):625-7. doi: 10.1111/j.1600-051x.1992.tb01709.x.</citation>
    <PMID>1430289</PMID>
  </reference>
  <reference>
    <citation>Hujoel PP. Design and analysis issues in split mouth clinical trials. Community Dent Oral Epidemiol. 1998 Apr;26(2):85-6. doi: 10.1111/j.1600-0528.1998.tb01932.x. No abstract available.</citation>
    <PMID>9645400</PMID>
  </reference>
  <reference>
    <citation>Cobb CM. Non-surgical pocket therapy: mechanical. Ann Periodontol. 1996 Nov;1(1):443-90. doi: 10.1902/annals.1996.1.1.443. No abstract available.</citation>
    <PMID>9118268</PMID>
  </reference>
  <reference>
    <citation>Bower RC. Furcation morphology relative to periodontal treatment. Furcation entrance architecture. J Periodontol. 1979 Jan;50(1):23-7. doi: 10.1902/jop.1979.50.1.23.</citation>
    <PMID>283222</PMID>
  </reference>
  <reference>
    <citation>Bower RC. Furcation morphology relative to periodontal treatment. Furcation root surface anatomy. J Periodontol. 1979 Jul;50(7):366-74. doi: 10.1902/jop.1979.50.7.366. No abstract available.</citation>
    <PMID>288913</PMID>
  </reference>
  <reference>
    <citation>Petersilka GJ, Tunkel J, Barakos K, Heinecke A, Haberlein I, Flemmig TF. Subgingival plaque removal at interdental sites using a low-abrasive air polishing powder. J Periodontol. 2003 Mar;74(3):307-11. doi: 10.1902/jop.2003.74.3.307.</citation>
    <PMID>12710749</PMID>
  </reference>
  <reference>
    <citation>Armitage GC. Analysis of gingival crevice fluid and risk of progression of periodontitis. Periodontol 2000. 2004;34:109-19. doi: 10.1046/j.0906-6713.2002.003427.x. No abstract available.</citation>
    <PMID>14717858</PMID>
  </reference>
  <reference>
    <citation>Tsang YC, Corbet EF, Jin LJ. Subgingival glycine powder air-polishing as an additional approach to nonsurgical periodontal therapy in subjects with untreated chronic periodontitis. J Periodontal Res. 2018 Jun;53(3):440-445. doi: 10.1111/jre.12532. Epub 2018 Mar 25.</citation>
    <PMID>29574763</PMID>
  </reference>
  <reference>
    <citation>Bunaes DF, Mustafa M, Mohamed HG, Lie SA, Leknes KN. The effect of smoking on inflammatory and bone remodeling markers in gingival crevicular fluid and subgingival microbiota following periodontal therapy. J Periodontal Res. 2017 Aug;52(4):713-724. doi: 10.1111/jre.12438. Epub 2017 Mar 17.</citation>
    <PMID>28306142</PMID>
  </reference>
  <reference>
    <citation>Hagi TT, Klemensberger S, Bereiter R, Nietzsche S, Cosgarea R, Flury S, Lussi A, Sculean A, Eick S. A Biofilm Pocket Model to Evaluate Different Non-Surgical Periodontal Treatment Modalities in Terms of Biofilm Removal and Reformation, Surface Alterations and Attachment of Periodontal Ligament Fibroblasts. PLoS One. 2015 Jun 29;10(6):e0131056. doi: 10.1371/journal.pone.0131056. eCollection 2015.</citation>
    <PMID>26121365</PMID>
  </reference>
  <reference>
    <citation>Antczak-Bouckoms AA, Tulloch JF, Berkey CS. Split-mouth and cross-over designs in dental research. J Clin Periodontol. 1990 Aug;17(7 Pt 1):446-53. doi: 10.1111/j.1600-051x.1990.tb02343.x.</citation>
    <PMID>2201705</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bergen</investigator_affiliation>
    <investigator_full_name>Knut N. Leknes</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Furcation involvement</keyword>
  <keyword>Periodontal maintenance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erythritol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493398
org study id: 2016/793
nct id: NCT04493398
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: To effectively disrupt microbial biofilm and remove dental calculus with minimal
      damage to the root surface and soft tissues with limited patient discomfort constitute a
      significant tenet of periodontal therapy. The aim of the present prospective 12-month study
      was to compare clinical and microbiological effects following an erythritol air-polishing vs.
      conventional mechanical debridement of furcation defects in a cohort of periodontal
      maintenance patients.

      Methods: Twenty patients with grade II mandibular molar furcation defects volunteered to
      enroll in this study. In a split-mouth design, two furcation sites in each patient were
      randomly assigned to either receive subgingival debridement using erythritol air-polishing
      (test) or conventional ultrasonic/curette debridement (control) at baseline, and at 3, 6, 9
      and 12 months. Probing depth, clinical attachment level and bleeding on probing were recorded
      at 3-month intervals. Subgingival microbiological samples obtained at baseline, 6 and 12
      months were analyzed using checkerboard DNA-DNA hybridization. Discomfort from treatment was
      scored at 12 months using a visual analogue scale.
INTRODUCTION.Traditionally, periodontal debridement is accomplished using curettes, sonic or
      ultrasonic scalers, all presenting comparable outcomes.1,2 However, periodic root
      instrumentation may lead to dental hard tissue3-6 and soft tissue damage,7 and sensitivity
      due to exposure of dentinal tubules.8-10 Air-polishing using low abrasive glycine or
      trehalose powder has been shown to reach similar clinical outcomes as hand and ultrasonic
      instrumentation, but with less hard tissue loss.11-16 Moreover, air-polishing provides
      superior outcomes relative to patient comfort and time efficiency.7,11,12,14 Recently, a low
      abrasive erythritol powder with comparable physical properties to glycine air-polishing
      powder was introduced for subgingival air-polishing.17 Erythritol, a non-toxic, chemically
      neutral and completely water-soluble polyol is widely used in food industry as an artificial
      sweetener. Two studies comparing conventional mechanical debridement with erythritol
      air-polishing, reported similar results in supportive periodontal therapy (SPT) relative to
      clinical and microbiological outcomes.18,19 Such observations are also reflected in a
      systematic review concluding that air-polishing systems as a monotherapy are comparable to
      conventional therapy in patients undergoing SPT in single- and multi-rooted teeth without
      furcations.20 Moreover, inhibitory effects on pathogenic bacteria including Porphyromonas
      gingivalis have also been observed.21 To the investigator's knowledge, no prospective studies
      investigating the efficacy of a low abrasive erythritol air-polishing system in molar
      furcation defects during SPT have been reported. The objective of this 12-month prospective
      study was to compare clinical and microbiological effects following an erythritol
      air-polishing system vs. conventional mechanical debridement of furcation defects in a cohort
      of periodontal maintenance patients.

      METHOD AND MATERIALS. The study protocol and informed consent following the Helsinki
      Declaration of 1975 (version 2008) was approved by the Medical Research Ethics Committee
      (2016/793), University of Bergen, Norway. Participating subjects read and signed the informed
      consent prior to enrolling in the study.

      Prestudy calibration and training. Two operators performed the clinical aspects of this
      study. Author TS, masked to treatment assignments, performed all clinical recordings and
      sampling, author IU performed all treatments.

      Sample size. The sample size estimation was based on change in PD. A difference of 0.5 mm was
      considered clinically relevant.22 Standard deviation of the difference between repeated PD
      measurements from the intra-calibration exercise was 0.5 mm. A power analysis based on 20
      subjects and with the level of significance (α) set to 0.05, resulted in 98.9% power to
      detect a true difference of 0.5 mm.

      Treatments. Following baseline examination, mandibular jaw quadrants were randomized (coin
      toss) to either receive debridement using the erythritol powder/air-polishing system (test)
      or conventional ultrasonic/curette instrumentation (control) using a split-mouth study
      design. Sequence of treatments was randomized in a similar fashion. Treatments were delivered
      at baseline, and repeated at 3, 6, 9 and 12 months. Test sites thus received root debridement
      using the low abrasive erythritol powder (Air-flow powder plus®, EMS, Nyon, Switzerland )
      applied through a Perio-Flow hand piece connected to an airflow unit (Air-Flow Master®, EMS,
      Nyon, Switzerland). The hand piece was fitted with a nozzle for subgingival delivery
      directing the power/air jet perpendicular to the root surface at the water exit at the tip of
      the nozzle. The nozzle was inserted to the apical aspect of furcation sites with PD≥ 4 mm
      using striking movements over the furcation area for 5 sec.12 Sites adjoining the test site
      with PD≥ 4 mm were similarly treated.

      Control sites were debrided using an ultrasonic scaler (Piezon Master 400 Perio Slim Tip®;
      Electro Medical System, Nyon, Switzerland) with power set at 75% and water as coolant, and
      root planed with sharp curettes (Gracey SAS, Hu-Friedy, Chicago, IL, USA).

      Patients were returned to their regular SPT upon completion of study. Gingival crevicular
      fluid assessments. Gingival crevicular fluid (GCF) was recorded at baseline, and at 6 and 12
      months. Briefly, furcation sites were isolated with cottons rolls, cleaned for supragingival
      plaque, and air-dried. A perio paper strip was then placed 1-2 mm into the orifice of the
      site and left in place for 30 sec. Next, the perio strip was inserted into the Periotron
      8000® (Oraflow, Smithtown, NY, USA) calibrated to estimate the volume of GCF collected.

      Microbiological assessments. At baseline, and at 6 and 12 months the supragingival area above
      the furcation site was wiped clean using sterile cotton pellets. Three sterile paper points
      were then inserted into the pocket of the furcation site. The paper points were kept in place
      20 sec27 removed and immersed into pre-reduced, anaerobic transport medium (PRAS; Dental
      Transport Medium, Morgan Hill, CA, USA).

      Pain experience assessments. Visual analogue scale (VAS) scores were used to estimate patient
      discomfort experienced during test and control treatment.31 Scoring was performed at 12
      months following completion of the debridement with 0="no pain" and 100="worst pain I can
      imagine".

      Statistical analysis Data were entered into MS-Excel (Microsoft, Redmond, WA, USA ) proofed
      for errors and then imported into Stata, version 15 (StataCorp, College Station, TX, USA).

      Summary statistics (means ± SEM) for the clinical variables were calculated for the test and
      control at baseline, and at 6 and 12 months. Due to the repeated nature of data, a mixed
      effect model taking into consideration incomplete data at 12 months was applied to analyze
      the data at patient and tooth level. Time and treatment were considered fixed factors. Mixed
      models were applied for both primary and secondary outcome variables.

      For testing differences in microbial composition at test and control sites harboring
      different proportions of bacteria >105 at baseline, and at 6 and 12 months, logistic
      regression models with robust standard error were applied. VAS scores were analyzed using
      ordinary linear regression models with robust standard error. The level of significance was
      set at 0.05.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized, single-masked controlled trial (RCT). A split-mouth study design where each of the furcation in the lower jaw molars was randomized to the two specific treatments. Hence, each patient received both interventions randomly allocated to each side of the lower jaw.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Two operators performed the clinical aspects of this study. Author TS, masked to treatment assignments, performed all clinical recordings and sampling, author IU performed all treatments. All analyses were performed by a statistician (SAL) who had not taken part in data collection or treatments.
measure: In 20 patients with grade II mandibular molar furcation defects, probing depth (PD) will be measured.
time frame: 12 months.
description: PD: The vertical distance from the gingival margin to the probable base of the pocket in mm.
measure: In 20 patients with grade II mandibular molar furcation defects clinical attachment level (CAL) will be measured.
time frame: 12 months.
description: CAL: The vertical distance in mm from the cemento-enamel junction or the margin of a dental restoration to the probable base of the pocket.
measure: Bleeding on probing (BoP).
time frame: 12 months.
description: At site level, BoP was recorded as present upon gentle probing to the base of the vertical furcation pocket.
measure: Gingival crevicular fluid (GCF).
time frame: 12 months.
description: Twenty test and control sites were isolated with cottons rolls, cleaned for supragingival plaque, and air-dried. A perio paper strip was then placed 1-2 mm into the orifice of the site and left in place for 30 sec. The perio strip was inserted into the Periotron 8000® (Oraflow, Smithtown, NY, USA) calibrated to estimate the volume of GCF collected.
measure: Visual analogue scale (VAS).
time frame: 12 months.
description: VAS scores were used to estimate patient discomfort experienced during test and control treatment by drawing a vertical line on a 100-millimeter standardized horizontal line (0="no pain" and 100="worst pain I can imagine").
arm group label: Titanium curette and ultrasonic.
arm group type: Active Comparator
description: Debridement of mandibular furcations with conventional ultrasonic/curette (control).
arm group label: Erythritol air-polishing.
arm group type: Experimental
description: Treatment of mandibular furcations with erythritol powder/air-polishing system (test)
intervention type: Procedure
intervention name: Gracey curette.
description: Root planed was performed with curettes (Gracey SAS, Hu-Friedy, Chicago, IL, USA).
arm group label: Titanium curette and ultrasonic.
intervention type: Procedure
intervention name: Ultrasonic scaler.
description: Debridement was performed with an ultrasonic scaler (Piezon Master 400 Perio Slim Tip®; Electro Medical System, Nyon, Switzerland).
arm group label: Titanium curette and ultrasonic.
intervention type: Procedure
intervention name: Erythritol air-polishing.
description: Treatment was performed with a low abrasive erythritol powder (Air-flow powder plus®, EMS, Nyon, Switzerland ) applied through a Perio-Flow hand piece connected to an airflow unit (Air-Flow Master®, EMS, Nyon, Switzerland).
arm group label: Erythritol air-polishing.
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Knut N. Leknes, Professor
role: Principal Investigator
affiliation: Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY.
citation: Wilson TG Jr. Supportive periodontal treatment introduction--definition, extent of need, therapeutic objectives, frequency and efficacy. Periodontol 2000. 1996 Oct;12:11-5. doi: 10.1111/j.1600-0757.1996.tb00074.x. No abstract available.
PMID: 9567987
citation: Badersten A, Nilveus R, Egelberg J. Effect of nonsurgical periodontal therapy. II. Severely advanced periodontitis. J Clin Periodontol. 1984 Jan;11(1):63-76. doi: 10.1111/j.1600-051x.1984.tb01309.x.
PMID: 6363463
citation: Zappa U, Smith B, Simona C, Graf H, Case D, Kim W. Root substance removal by scaling and root planing. J Periodontol. 1991 Dec;62(12):750-4. doi: 10.1902/jop.1991.62.12.750.
PMID: 1765938
citation: Flemmig TF, Petersilka GJ, Mehl A, Hickel R, Klaiber B. Working parameters of a magnetostrictive ultrasonic scaler influencing root substance removal in vitro. J Periodontol. 1998 May;69(5):547-53. doi: 10.1902/jop.1998.69.5.547.
PMID: 9623897
citation: Lie T, Leknes KN. Evaluation of the effect on root surfaces of air turbine scalers and ultrasonic instrumentation. J Periodontol. 1985 Sep;56(9):522-31. doi: 10.1902/jop.1985.56.9.522.
PMID: 3897504
citation: Schmidlin PR, Beuchat M, Busslinger A, Lehmann B, Lutz F. Tooth substance loss resulting from mechanical, sonic and ultrasonic root instrumentation assessed by liquid scintillation. J Clin Periodontol. 2001 Nov;28(11):1058-66. doi: 10.1034/j.1600-051x.2001.281111.x.
PMID: 11686828
citation: Petersilka GJ. Subgingival air-polishing in the treatment of periodontal biofilm infections. Periodontol 2000. 2011 Feb;55(1):124-42. doi: 10.1111/j.1600-0757.2010.00342.x. No abstract available.
PMID: 21134232
citation: Fischer C, Wennberg A, Fischer RG, Attstrom R. Clinical evaluation of pulp and dentine sensitivity after supragingival and subgingival scaling. Endod Dent Traumatol. 1991 Dec;7(6):259-65. doi: 10.1111/j.1600-9657.1991.tb00214.x.
PMID: 1820859
citation: Latheef P, Sirajuddin S, Gundapaneni V, Mn K, Apine A. Iatrogenic Damage to the Periodontium Caused by Periodontal Treatment Procedures. Open Dent J. 2015 Jun 26;9:203-7. doi: 10.2174/1874210601509010203. eCollection 2015.
PMID: 26312087
citation: Lin YH, Gillam DG. The Prevalence of Root Sensitivity following Periodontal Therapy: A Systematic Review. Int J Dent. 2012;2012:407023. doi: 10.1155/2012/407023. Epub 2012 Oct 31.
PMID: 23193405
citation: Petersilka GJ, Steinmann D, Haberlein I, Heinecke A, Flemmig TF. Subgingival plaque removal in buccal and lingual sites using a novel low abrasive air-polishing powder. J Clin Periodontol. 2003 Apr;30(4):328-33. doi: 10.1034/j.1600-051x.2003.00290.x.
PMID: 12694431
citation: Petersilka G. Re: "Subgingival plaque removal using a new air-polishing device". Moene R, Decaillet F, Andersen E, Mombelli A. (J Periodontol 2010;81:79-88.). J Periodontol. 2010 Jul;81(7):962-3. doi: 10.1902/jop.2010.100118. No abstract available.
PMID: 20553116
citation: Flemmig TF, Arushanov D, Daubert D, Rothen M, Mueller G, Leroux BG. Randomized controlled trial assessing efficacy and safety of glycine powder air polishing in moderate-to-deep periodontal pockets. J Periodontol. 2012 Apr;83(4):444-52. doi: 10.1902/jop.2011.110367. Epub 2011 Aug 23.
PMID: 21861637
citation: Wennstrom JL, Dahlen G, Ramberg P. Subgingival debridement of periodontal pockets by air polishing in comparison with ultrasonic instrumentation during maintenance therapy. J Clin Periodontol. 2011 Sep;38(9):820-7. doi: 10.1111/j.1600-051X.2011.01751.x. Epub 2011 Jul 7.
PMID: 21736599
citation: Caygur A, Albaba MR, Berberoglu A, Yilmaz HG. Efficacy of glycine powder air-polishing combined with scaling and root planing in the treatment of periodontitis and halitosis: A randomised clinical study. J Int Med Res. 2017 Jun;45(3):1168-1174. doi: 10.1177/0300060517705540. Epub 2017 Apr 20.
PMID: 28425827
citation: Kruse AB, Akakpo DL, Maamar R, Woelber JP, Al-Ahmad A, Vach K, Ratka-Krueger P. Trehalose powder for subgingival air-polishing during periodontal maintenance therapy: A randomized controlled trial. J Periodontol. 2019 Mar;90(3):263-270. doi: 10.1002/JPER.17-0403. Epub 2018 Nov 9.
PMID: 30311948
citation: Hagi TT, Hofmanner P, Salvi GE, Ramseier CA, Sculean A. Clinical outcomes following subgingival application of a novel erythritol powder by means of air polishing in supportive periodontal therapy: a randomized, controlled clinical study. Quintessence Int. 2013 Nov-Dec;44(10):753-61. doi: 10.3290/j.qi.a30606.
PMID: 24078975
citation: Hagi TT, Hofmanner P, Eick S, Donnet M, Salvi GE, Sculean A, Ramseier CA. The effects of erythritol air-polishing powder on microbiologic and clinical outcomes during supportive periodontal therapy: Six-month results of a randomized controlled clinical trial. Quintessence Int. 2015 Jan;46(1):31-41. doi: 10.3290/j.qi.a32817.
PMID: 25262675
citation: Muller N, Moene R, Cancela JA, Mombelli A. Subgingival air-polishing with erythritol during periodontal maintenance: randomized clinical trial of twelve months. J Clin Periodontol. 2014 Sep;41(9):883-9. doi: 10.1111/jcpe.12289. Epub 2014 Aug 7.
PMID: 25041441
citation: Ng E, Byun R, Spahr A, Divnic-Resnik T. The efficacy of air polishing devices in supportive periodontal therapy: A systematic review and meta-analysis. Quintessence Int. 2018;49(6):453-467. doi: 10.3290/j.qi.a40341.
PMID: 29700503
citation: Hashino E, Kuboniwa M, Alghamdi SA, Yamaguchi M, Yamamoto R, Cho H, Amano A. Erythritol alters microstructure and metabolomic profiles of biofilm composed of Streptococcus gordonii and Porphyromonas gingivalis. Mol Oral Microbiol. 2013 Dec;28(6):435-51. doi: 10.1111/omi.12037. Epub 2013 Jul 29.
PMID: 23890177
citation: Bunaes DF, Lie SA, Enersen M, Aastrom AN, Mustafa K, Leknes KN. Site-specific treatment outcome in smokers following non-surgical and surgical periodontal therapy. J Clin Periodontol. 2015 Oct;42(10):933-42. doi: 10.1111/jcpe.12462. Epub 2015 Oct 28.
PMID: 26407817
citation: Muhlemann HR, Son S. Gingival sulcus bleeding--a leading symptom in initial gingivitis. Helv Odontol Acta. 1971 Oct;15(2):107-13. No abstract available.
PMID: 5315729
citation: O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
PMID: 4500182
citation: Hamp SE, Nyman S, Lindhe J. Periodontal treatment of multirooted teeth. Results after 5 years. J Clin Periodontol. 1975 Aug;2(3):126-35. doi: 10.1111/j.1600-051x.1975.tb01734.x.
PMID: 1058213
citation: Barros SP, Williams R, Offenbacher S, Morelli T. Gingival crevicular fluid as a source of biomarkers for periodontitis. Periodontol 2000. 2016 Feb;70(1):53-64. doi: 10.1111/prd.12107.
PMID: 26662482
citation: Belibasakis GN, Schmidlin PR, Sahrmann P. Molecular microbiological evaluation of subgingival biofilm sampling by paper point and curette. APMIS. 2014 Apr;122(4):347-52. doi: 10.1111/apm.12151. Epub 2013 Jul 24.
PMID: 23879704
citation: Socransky SS, Haffajee AD, Smith C, Martin L, Haffajee JA, Uzel NG, Goodson JM. Use of checkerboard DNA-DNA hybridization to study complex microbial ecosystems. Oral Microbiol Immunol. 2004 Dec;19(6):352-62. doi: 10.1111/j.1399-302x.2004.00168.x.
PMID: 15491460
citation: Socransky SS, Smith C, Martin L, Paster BJ, Dewhirst FE, Levin AE. "Checkerboard" DNA-DNA hybridization. Biotechniques. 1994 Oct;17(4):788-92.
PMID: 7833043
citation: Socransky SS, Haffajee AD, Cugini MA, Smith C, Kent RL Jr. Microbial complexes in subgingival plaque. J Clin Periodontol. 1998 Feb;25(2):134-44. doi: 10.1111/j.1600-051x.1998.tb02419.x.
PMID: 9495612
citation: Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
PMID: 2197679
citation: Krohn-Dale I, Boe OE, Enersen M, Leknes KN. Er:YAG laser in the treatment of periodontal sites with recurring chronic inflammation: a 12-month randomized, controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):745-52. doi: 10.1111/j.1600-051X.2012.01912.x. Epub 2012 Jun 13.
PMID: 22694321
citation: Hujoel PP, Loesche WJ. Efficiency of split-mouth designs. J Clin Periodontol. 1990 Nov;17(10):722-8. doi: 10.1111/j.1600-051x.1990.tb01060.x.
PMID: 2262586
citation: Hujoel PP, DeRouen TA. Validity issues in split-mouth trials. J Clin Periodontol. 1992 Oct;19(9 Pt 1):625-7. doi: 10.1111/j.1600-051x.1992.tb01709.x.
PMID: 1430289
citation: Hujoel PP. Design and analysis issues in split mouth clinical trials. Community Dent Oral Epidemiol. 1998 Apr;26(2):85-6. doi: 10.1111/j.1600-0528.1998.tb01932.x. No abstract available.
PMID: 9645400
citation: Cobb CM. Non-surgical pocket therapy: mechanical. Ann Periodontol. 1996 Nov;1(1):443-90. doi: 10.1902/annals.1996.1.1.443. No abstract available.
PMID: 9118268
citation: Bower RC. Furcation morphology relative to periodontal treatment. Furcation entrance architecture. J Periodontol. 1979 Jan;50(1):23-7. doi: 10.1902/jop.1979.50.1.23.
PMID: 283222
citation: Bower RC. Furcation morphology relative to periodontal treatment. Furcation root surface anatomy. J Periodontol. 1979 Jul;50(7):366-74. doi: 10.1902/jop.1979.50.7.366. No abstract available.
PMID: 288913
citation: Petersilka GJ, Tunkel J, Barakos K, Heinecke A, Haberlein I, Flemmig TF. Subgingival plaque removal at interdental sites using a low-abrasive air polishing powder. J Periodontol. 2003 Mar;74(3):307-11. doi: 10.1902/jop.2003.74.3.307.
PMID: 12710749
citation: Armitage GC. Analysis of gingival crevice fluid and risk of progression of periodontitis. Periodontol 2000. 2004;34:109-19. doi: 10.1046/j.0906-6713.2002.003427.x. No abstract available.
PMID: 14717858
citation: Tsang YC, Corbet EF, Jin LJ. Subgingival glycine powder air-polishing as an additional approach to nonsurgical periodontal therapy in subjects with untreated chronic periodontitis. J Periodontal Res. 2018 Jun;53(3):440-445. doi: 10.1111/jre.12532. Epub 2018 Mar 25.
PMID: 29574763
citation: Bunaes DF, Mustafa M, Mohamed HG, Lie SA, Leknes KN. The effect of smoking on inflammatory and bone remodeling markers in gingival crevicular fluid and subgingival microbiota following periodontal therapy. J Periodontal Res. 2017 Aug;52(4):713-724. doi: 10.1111/jre.12438. Epub 2017 Mar 17.
PMID: 28306142
citation: Hagi TT, Klemensberger S, Bereiter R, Nietzsche S, Cosgarea R, Flury S, Lussi A, Sculean A, Eick S. A Biofilm Pocket Model to Evaluate Different Non-Surgical Periodontal Treatment Modalities in Terms of Biofilm Removal and Reformation, Surface Alterations and Attachment of Periodontal Ligament Fibroblasts. PLoS One. 2015 Jun 29;10(6):e0131056. doi: 10.1371/journal.pone.0131056. eCollection 2015.
PMID: 26121365
citation: Antczak-Bouckoms AA, Tulloch JF, Berkey CS. Split-mouth and cross-over designs in dental research. J Clin Periodontol. 1990 Aug;17(7 Pt 1):446-53. doi: 10.1111/j.1600-051x.1990.tb02343.x.
PMID: 2201705
responsible party type: Principal Investigator
investigator affiliation: University of Bergen
investigator full name: Knut N. Leknes
investigator title: Professor
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Erythritol
sharing ipd: No