<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/NCT03241953</url>
  </required_header>
  <id_info>
    <org_study_id>2014-08</org_study_id>
    <nct_id>NCT03241953</nct_id>
  </id_info>
  <brief_title>COMPARISION OF DIFFERENT TREATMENT METHODS OF PERI-IMPLANTITIS</brief_title>
  <official_title>COMPARISION OF DIFFERENT TREATMENT METHODS OF PERI-IMPLANTITIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Necmettin Erbakan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Necmettin Erbakan University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this randomized, controlled study, 18 patients with peri-implantitis were included. A&#xD;
      total of forty dental implants were debrided with either ultrasonic instruments (test, n=20)&#xD;
      or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width&#xD;
      (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months.&#xD;
      CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical&#xD;
      periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the&#xD;
      surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces&#xD;
      was removed by ultrasonic scaler and air polishing using abrasive powders or conventional&#xD;
      plastic scaler with klorhegsidin combination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subject selection 18 systemically healthy patients, who applied to the Department of&#xD;
      Periodontology, Necmettin Erbakan University and whose at least 1 dental implant was&#xD;
      diagnosed by peri-implantitis and who has never taken peri-implantitis therapy, were included&#xD;
      in the study. All patients were informed about the study and given informed consent form, and&#xD;
      only volunteers were included. The research was conducted in accordance with the principles&#xD;
      outlined in the Declaration of Helsinki. This prospective clinical study was approved by the&#xD;
      Research Ethics Committee of Necmettin Erbakan University.&#xD;
&#xD;
      The patients, who were systemically and periodontally healthy and free of parafunctional&#xD;
      habits like bruxism, and didn't have any kind of periodontal therapy within the previous year&#xD;
      and had implants for at least 5 years, were included in the study. In addition, the inclusion&#xD;
      criteria were as follows: having pocket depth over 5mm in implants diagnosed by&#xD;
      peri-implantitis (Figure 1), having no mobility, having bone loss in implant site that is&#xD;
      needed for augmentation(Figure 2). The patients with chronic bronchitis or asthma and major&#xD;
      systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders&#xD;
      that compromise wound healing, radiation or immunosuppressive therapy) and those who had&#xD;
      taken antibiotics, anti-inflammatory drugs or other medication within the previous 28 days&#xD;
      were excluded in the study.&#xD;
&#xD;
      18 patients (mean age 52 years) diagnosed by peri- implantitis were included in this&#xD;
      randomized and controlled study. A total of forty dental implants were debrided with either&#xD;
      standard plastic curettes, debridement made by combined klorhegsidin rinse(control, n=20) or&#xD;
      mechanical debridement made by ultrasonic polyetheretherketone coated tips developed for&#xD;
      implant surface and combined air-flow debridement (test, n=20).&#xD;
&#xD;
      Clinical Measurements The clinical parameters given below were observed on six sites of all&#xD;
      implants: Plaque Index (PlI; Silness &amp; Lo€e 1964), PD, Bleeding upon Probing (BOP) and&#xD;
      Gingival Recession (RD; gingival margin location measuremant cemento- enamel junction to&#xD;
      Gingival marjin).&#xD;
&#xD;
      On six sites of all implants, the following clinical parameters were recorded: Plaque Index&#xD;
      (PlI; Silness &amp; Lo€e 1964), PD, Bleeding on Probing (BOP) and Gingival Recession (RD;&#xD;
      gingival margin location measuremant cemento- enamel junction to Gingival marjin).&#xD;
&#xD;
      Keratinized tissue width (KTW) was measured at buccal midpoint of implants. Bone loss volume&#xD;
      was recorded on con-beam computed tomographs (CBCT) by measuring the distance from bone&#xD;
      implant abutment placement to alveolar bone level. All measurements were taken at the&#xD;
      beginning. As we didn't perform any regenerative operations and didn't want the patients to&#xD;
      be subjected to X-rays again, no more tomographs were taken.&#xD;
&#xD;
      Phase I Periodontal Therapy Upon the recordings, all patients were given Phase 1 periodontal&#xD;
      therapy and informed about hygiene control. Prior to surgical operation, professional&#xD;
      supragingival and subgingival debridement was performed during 2 or 4 appointments. The&#xD;
      patients with a good level of oral hygiene were included in the study. Oral hygiene controls&#xD;
      were performed in the first, third and sixth months prior to and after operations. Occlusion&#xD;
      controls of all implant supported dental prosthesis were performed, and if present, extreme&#xD;
      contacts were removed.&#xD;
&#xD;
      Phase II Periodontal Therapy 4 weeks after the initial periodontal treatments, for the&#xD;
      treatment of the sites with pocket depth deeper than 5mm, flap operation was performed to&#xD;
      achieve a direct reach to implant surfaces. Around affected implants, intrasulcular incisions&#xD;
      were performed and mucoperiostal flaps with full thickness were raised both buccally and&#xD;
      palatally. Implant surface decontamination is performed using with either plastic curettes or&#xD;
      ultrasonic scaler (Figure 3); In control group, plastic curettes (Hue-Friedy Co., Chicago,&#xD;
      IL, USA) were used for debridement and implant surfaces were decontaminated by klorhegsidin&#xD;
      solution. In test group, sub-gingival operations with ultrasonic scaler was for nearly 20s&#xD;
      per site (EMS Master Piezon LED, implant care system, Nyon, Switzerland). A special design&#xD;
      disposable thermoplastic elastomer nozzle (Perio-flow Nozzle EMS Electro Medical Systems,&#xD;
      Nyon, Sweden.), which horizontally gives out the glycine powder, was utilized.&#xD;
&#xD;
      The hand-device (Air-Flows EL-308/A; EMS Electro Medical Systems, Nyon, Sweden) was used in a&#xD;
      circular motion, from coronal to apical, parallel to the implant surface in a noncontact&#xD;
      mode. The operation period time at each aspect (i.e. mesial, distal, vestibular and oral) was&#xD;
      limited to 5 s, as suggested by the manufacturer 35. The nozzle was moved with a&#xD;
      circumferential movement around the implant to cover the entire exposed implant surface (36).&#xD;
&#xD;
      After the debriding of implant surfaces the flap was sutured by 4-0 vicryl. After the&#xD;
      operation, for antimicrobial treatment chlorhexidine was used for 10 days. The sutures were&#xD;
      removed 10 days after the operation and post-operative controls were performed. The patients&#xD;
      were invited to the followups in the first, third and sixth month after the operation.&#xD;
      Clinical and radiographic measurements were repeated every six months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 23, 2014</start_date>
  <completion_date type="Actual">December 22, 2016</completion_date>
  <primary_completion_date type="Actual">November 20, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment results</measure>
    <time_frame>one year</time_frame>
    <description>It was found in the study that the combined air-flow debridement and the mechanical debridement performed by using ultrasonic polyetheretherketone-coated tips developed for implant surface debridement in peri-implantitis therapy were better at decreasing the level of periodontal pocket depth than plastic curettes</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Peri-Implantitis</condition>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>debridement made by ultrasonic tips</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mechanical debridement made by ultrasonic polyetheretherketone coated tips developed for implant surface and combined air-flow debridement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>implants were debrided with standard plastic curettes</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>dental implants were debrided with standard plastic curettes, debridement made by combined klorhegsidin rinse</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Periodontal surgery</intervention_name>
    <description>A total of forty dental implants were debrided with either ultrasonic instruments (test, n=20) or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months. CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces was removed by ultrasonic scaler and air polishing</description>
    <arm_group_label>debridement made by ultrasonic tips</arm_group_label>
    <arm_group_label>implants were debrided with standard plastic curettes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - The patients, who were systemically and periodontally healthy and free of parafunctional&#xD;
        habits like bruxism, and didn't have any kind of periodontal therapy within the previous&#xD;
        year and had implants for at least 5 years, were included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients with chronic bronchitis or asthma and major systemic illnesses (i.e.&#xD;
             diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders that compromise&#xD;
             wound healing, radiation or immunosuppressive therapy) and those who had taken&#xD;
             antibiotics, anti-inflammatory drugs or other medication within the previous 28 days&#xD;
             were excluded in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/21770995</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/21251076</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Necmettin Erbakan University</investigator_affiliation>
    <investigator_full_name>ELİF ONCU</investigator_full_name>
    <investigator_title>Asist.Prof.Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
    <mesh_term>Peri-Implantitis</mesh_term>
  </condition_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/NCT03241953
org study id: 2014-08
nct id: NCT03241953
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this randomized, controlled study, 18 patients with peri-implantitis were included. A
      total of forty dental implants were debrided with either ultrasonic instruments (test, n=20)
      or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width
      (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months.
      CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical
      periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the
      surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces
      was removed by ultrasonic scaler and air polishing using abrasive powders or conventional
      plastic scaler with klorhegsidin combination.
Subject selection 18 systemically healthy patients, who applied to the Department of
      Periodontology, Necmettin Erbakan University and whose at least 1 dental implant was
      diagnosed by peri-implantitis and who has never taken peri-implantitis therapy, were included
      in the study. All patients were informed about the study and given informed consent form, and
      only volunteers were included. The research was conducted in accordance with the principles
      outlined in the Declaration of Helsinki. This prospective clinical study was approved by the
      Research Ethics Committee of Necmettin Erbakan University.

      The patients, who were systemically and periodontally healthy and free of parafunctional
      habits like bruxism, and didn't have any kind of periodontal therapy within the previous year
      and had implants for at least 5 years, were included in the study. In addition, the inclusion
      criteria were as follows: having pocket depth over 5mm in implants diagnosed by
      peri-implantitis (Figure 1), having no mobility, having bone loss in implant site that is
      needed for augmentation(Figure 2). The patients with chronic bronchitis or asthma and major
      systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders
      that compromise wound healing, radiation or immunosuppressive therapy) and those who had
      taken antibiotics, anti-inflammatory drugs or other medication within the previous 28 days
      were excluded in the study.

      18 patients (mean age 52 years) diagnosed by peri- implantitis were included in this
      randomized and controlled study. A total of forty dental implants were debrided with either
      standard plastic curettes, debridement made by combined klorhegsidin rinse(control, n=20) or
      mechanical debridement made by ultrasonic polyetheretherketone coated tips developed for
      implant surface and combined air-flow debridement (test, n=20).

      Clinical Measurements The clinical parameters given below were observed on six sites of all
      implants: Plaque Index (PlI; Silness & Lo€e 1964), PD, Bleeding upon Probing (BOP) and
      Gingival Recession (RD; gingival margin location measuremant cemento- enamel junction to
      Gingival marjin).

      On six sites of all implants, the following clinical parameters were recorded: Plaque Index
      (PlI; Silness & Lo€e 1964), PD, Bleeding on Probing (BOP) and Gingival Recession (RD;
      gingival margin location measuremant cemento- enamel junction to Gingival marjin).

      Keratinized tissue width (KTW) was measured at buccal midpoint of implants. Bone loss volume
      was recorded on con-beam computed tomographs (CBCT) by measuring the distance from bone
      implant abutment placement to alveolar bone level. All measurements were taken at the
      beginning. As we didn't perform any regenerative operations and didn't want the patients to
      be subjected to X-rays again, no more tomographs were taken.

      Phase I Periodontal Therapy Upon the recordings, all patients were given Phase 1 periodontal
      therapy and informed about hygiene control. Prior to surgical operation, professional
      supragingival and subgingival debridement was performed during 2 or 4 appointments. The
      patients with a good level of oral hygiene were included in the study. Oral hygiene controls
      were performed in the first, third and sixth months prior to and after operations. Occlusion
      controls of all implant supported dental prosthesis were performed, and if present, extreme
      contacts were removed.

      Phase II Periodontal Therapy 4 weeks after the initial periodontal treatments, for the
      treatment of the sites with pocket depth deeper than 5mm, flap operation was performed to
      achieve a direct reach to implant surfaces. Around affected implants, intrasulcular incisions
      were performed and mucoperiostal flaps with full thickness were raised both buccally and
      palatally. Implant surface decontamination is performed using with either plastic curettes or
      ultrasonic scaler (Figure 3); In control group, plastic curettes (Hue-Friedy Co., Chicago,
      IL, USA) were used for debridement and implant surfaces were decontaminated by klorhegsidin
      solution. In test group, sub-gingival operations with ultrasonic scaler was for nearly 20s
      per site (EMS Master Piezon LED, implant care system, Nyon, Switzerland). A special design
      disposable thermoplastic elastomer nozzle (Perio-flow Nozzle EMS Electro Medical Systems,
      Nyon, Sweden.), which horizontally gives out the glycine powder, was utilized.

      The hand-device (Air-Flows EL-308/A; EMS Electro Medical Systems, Nyon, Sweden) was used in a
      circular motion, from coronal to apical, parallel to the implant surface in a noncontact
      mode. The operation period time at each aspect (i.e. mesial, distal, vestibular and oral) was
      limited to 5 s, as suggested by the manufacturer 35. The nozzle was moved with a
      circumferential movement around the implant to cover the entire exposed implant surface (36).

      After the debriding of implant surfaces the flap was sutured by 4-0 vicryl. After the
      operation, for antimicrobial treatment chlorhexidine was used for 10 days. The sutures were
      removed 10 days after the operation and post-operative controls were performed. The patients
      were invited to the followups in the first, third and sixth month after the operation.
      Clinical and radiographic measurements were repeated every six months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Treatment results
time frame: one year
description: It was found in the study that the combined air-flow debridement and the mechanical debridement performed by using ultrasonic polyetheretherketone-coated tips developed for implant surface debridement in peri-implantitis therapy were better at decreasing the level of periodontal pocket depth than plastic curettes
arm group label: debridement made by ultrasonic tips
arm group type: Experimental
description: mechanical debridement made by ultrasonic polyetheretherketone coated tips developed for implant surface and combined air-flow debridement
arm group label: implants were debrided with standard plastic curettes
arm group type: Active Comparator
description: dental implants were debrided with standard plastic curettes, debridement made by combined klorhegsidin rinse
intervention type: Procedure
intervention name: Periodontal surgery
description: A total of forty dental implants were debrided with either ultrasonic instruments (test, n=20) or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months. CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces was removed by ultrasonic scaler and air polishing
arm group label: debridement made by ultrasonic tips
arm group label: implants were debrided with standard plastic curettes
criteria: 
gender: All
gender based: Yes
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
url: https://www.ncbi.nlm.nih.gov/pubmed/21770995
description: Related Info
url: https://www.ncbi.nlm.nih.gov/pubmed/21251076
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Necmettin Erbakan University
investigator full name: ELİF ONCU
investigator title: Asist.Prof.Dr.
mesh term: Periodontal Diseases
mesh term: Peri-Implantitis
sharing ipd: No