xml: <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/NCT05979805</url>
    </required_header>
    <id_info>
      <org_study_id>ECA 103-23</org_study_id>
      <nct_id>NCT05979805</nct_id>
    </id_info>
    <brief_title>Effectiveness of Educational Interventions in the Prevention of Caries in Patients With Orthodontics</brief_title>
    <official_title>Effectiveness of Motivational Interviewing and Conventional Interventions in the Prevention of Vestibular Caries in Patients With Fixed Orthodontic Appliances: a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Nacional de Colombia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidad Nacional de Colombia</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>
        Dental caries is classified by the World Health Organization (WHO) as an important public&#xD;
        health problem due to its high prevalence and incidence worldwide despite the development of&#xD;
        public policies to combat it. It is a chronic disease that has a severe impact in terms of&#xD;
        pain and suffering, impairment of function and effect on quality of life. During orthodontic&#xD;
        treatments, the most common adverse event is the appearance of dental caries lesions due to&#xD;
        increased retention, change of dental biofilm composition or difficulty of removal with&#xD;
        conventional oral hygiene techniques. Efforts to implement various conventional preventive&#xD;
        interventions of self-care and education have not decreased its incidence, so it is necessary&#xD;
        to implement motivational interventions to help adolescents and young adults to make positive&#xD;
        changes in their oral health habits, which are constant and lasting and prevent and control&#xD;
        caries.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dental caries is a multifactorial disease but the only necessary factor, although&#xD;
        insufficient for its development, is bacterial biofilm; brackets significantly increase its&#xD;
        retention and limit self- cleaning mechanisms, representing a challenge in clinical practice.&#xD;
        Motivational interventions in oral health could be an alternative to generate behavioral&#xD;
        changes in oral health and daily self-care routines that are more sustainable over time&#xD;
        compared to conventional education models in patients with fixed orthodontic appliances.&#xD;
  &#xD;
        A controlled, randomized, parallel and pragmatic clinical study is proposed for the&#xD;
        evaluation of the effect of conventional educational intervention and motivational&#xD;
        interviewing in comparison with conventional educational interventions in the prevention of&#xD;
        dental caries lesions. A sample size of 94 patients in total is proposed, distributed 47 in&#xD;
        each arm of the study, with a follow-up of the cohort for six months. The baseline risk will&#xD;
        be established before the placement of fixed appliances (T0), and a follow-up will be carried&#xD;
        out during six months, with assessments in one (T1), three(T2) and six months (T3) after&#xD;
        cementation, where the presence of caries and changes in risk variables, adverse events and&#xD;
        adherence to conventional and motivational interventions, will be measured.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">September 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 20, 2024</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>
      <intervention_model_description>A controlled, randomized, parallel and pragmatic clinical study is proposed for the evaluation of the effect of conventional educational interventions and motivational interviewing in comparison with conventional educational interventions, in the prevention of dental caries lesions in 94 patients aged 13 to 44 years old, who will begin corrective orthodontic treatment with fixed appliances in the postgraduate clinics of Orthodontics and Maxillary Orthopedics of the National University of Colombia.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>The examiner calibrated and certified in the International Caries Detection and Assessment System (ICDAS) visual diagnostic criteria for dental caries at T0, T1, T2 and T3 (primary outcome)&#xD;
  The examiner calibrated in measurement of risk variables (secondary outcomes) like plaque index, habits of oral hygiene and habits in sugar consumption.&#xD;
  Statistician</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in ICDAS score of the caries</measure>
      <time_frame>6 months</time_frame>
      <description>Change in incidence of caries on the vestibular surface by ICDAS in T0 (baseline),T1 (1 month),T2 (3 months) and T3 (6 months) will be censured when the patient presents the outcome, the study period ends (six months) or when the follow-up period finishes for a reason other than the event of interest being studied.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change of Plaque index</measure>
      <time_frame>6 months</time_frame>
      <description>Changes in modification of the Silness and Löe index described by Williams at T0 (baseline), T1 (one month), T2 (three months) and T3 (six months) after the start of orthodontic treatment with fixed appliances.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Adverse events</measure>
      <time_frame>6 months</time_frame>
      <description>Measurement of possible adverse events during educational interventional at T0 (baseline), T1 (one month), T2 (three months) and T3 (six months) after the start of orthodontic treatment with fixed appliances.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">94</enrollment>
    <condition>Dental Caries</condition>
    <condition>Tooth Demineralization</condition>
    <arm_group>
      <arm_group_label>Conventional Oral health Education</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Conventional oral health education and nutritional guidelines prior to the placement of fixed appliances, by means of a 5-8 minute video and instructive brochure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Motivational interviewing + Conventional Oral health Education</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Include the conventional oral health education of the control group and a 30 minute motivational interviewing (MI)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional Educational interventions</intervention_name>
      <description>Conventional educational methods can be verbal, written or visual and can be combined for greater understanding and effectiveness in oral health and dietary routines. The education are imparted in the first appointment of the appliances cementation by a video and oral health instruction booklet and each patient receive an oral hygiene kit. This education is repeated in month 1 and 3 after appliances cementation.</description>
      <arm_group_label>Conventional Oral health Education</arm_group_label>
      <arm_group_label>Motivational interviewing + Conventional Oral health Education</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Motivational intervention</intervention_name>
      <description>In addition to the conventional educational method, a motivational interviewing (MI) by Miller and Rollnick of 30 minutes will be used, with an initial script according to the stage of change in each patient in T0. The reinforcements of motivational interviewing are in month one and three after the installation of the braces, they will have the same methodology but will be focused on the aspects that in the previous session or in the clinical assessment were detected as the most important deficiencies or risk factors for the patient.</description>
      <arm_group_label>Motivational interviewing + Conventional Oral health Education</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients enrolled in the different orthodontic postgraduate clinics of the National&#xD;
               University of Colombia who requires treatment with fixed orthodontic appliances&#xD;
  &#xD;
            -  13 years old up to 44 years of age.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with untreated caries lesions&#xD;
  &#xD;
            -  Patients with periodontal diseases&#xD;
  &#xD;
            -  Previous orthodontics treatments&#xD;
  &#xD;
            -  Severe fluorosis or enamel abnormalities.&#xD;
  &#xD;
            -  Medical compromise&#xD;
  &#xD;
            -  Medical treatments generating hyposalivation or gingival enlargement,&#xD;
  &#xD;
            -  Craniomaxillary anomalies&#xD;
  &#xD;
            -  Cognitive or motor disability&#xD;
  &#xD;
            -  Pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>44 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Adriana Forero Niño, DDs</last_name>
      <role>Principal Investigator</role>
      <affiliation>111211</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Adriana Forero Niño, DDs</last_name>
      <phone>(571) 3102416420</phone>
      <email>apforeron@unal.edu.co</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jorge Rubio Romero, MD MSc</last_name>
      <phone>(571) 3165000</phone>
      <phone_ext>15122</phone_ext>
      <email>jarubior@unal.edu.co</email>
    </overall_contact_backup>
    <reference>
      <citation>Sundararaj D, Venkatachalapathy S, Tandon A, Pereira A. Critical evaluation of incidence and prevalence of white spot lesions during fixed orthodontic appliance treatment: A meta-analysis. J Int Soc Prev Community Dent. 2015 Nov-Dec;5(6):433-9. doi: 10.4103/2231-0762.167719.</citation>
      <PMID>26759794</PMID>
    </reference>
    <reference>
      <citation>Shimpo Y, Nomura Y, Sekiya T, Arai C, Okada A, Sogabe K, Hanada N, Tomonari H. Effects of the Dental Caries Preventive Procedure on the White Spot Lesions during Orthodontic Treatment-An Open Label Randomized Controlled Trial. J Clin Med. 2022 Feb 6;11(3):854. doi: 10.3390/jcm11030854.</citation>
      <PMID>35160305</PMID>
    </reference>
    <reference>
      <citation>Martignon S, Ekstrand KR, Lemos MI, Lozano MP, Higuera C. Plaque, caries level and oral hygiene habits in young patients receiving orthodontic treatment. Community Dent Health. 2010 Sep;27(3):133-8.</citation>
      <PMID>21046903</PMID>
    </reference>
    <reference>
      <citation>Chapman JA, Roberts WE, Eckert GJ, Kula KS, Gonzalez-Cabezas C. Risk factors for incidence and severity of white spot lesions during treatment with fixed orthodontic appliances. Am J Orthod Dentofacial Orthop. 2010 Aug;138(2):188-94. doi: 10.1016/j.ajodo.2008.10.019.</citation>
      <PMID>20691360</PMID>
    </reference>
    <reference>
      <citation>Ogaard B, Rolla G, Arends J. Orthodontic appliances and enamel demineralization. Part 1. Lesion development. Am J Orthod Dentofacial Orthop. 1988 Jul;94(1):68-73. doi: 10.1016/0889-5406(88)90453-2.</citation>
      <PMID>3164585</PMID>
    </reference>
    <reference>
      <citation>Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.</citation>
      <PMID>21208070</PMID>
    </reference>
    <reference>
      <citation>Fejerskov O. Concepts of dental caries and their consequences for understanding the disease. Community Dent Oral Epidemiol. 1997 Feb;25(1):5-12. doi: 10.1111/j.1600-0528.1997.tb00894.x.</citation>
      <PMID>9088687</PMID>
    </reference>
    <reference>
      <citation>Scheerman JFM, van Empelen P, van Loveren C, Pakpour AH, van Meijel B, Gholami M, Mierzaie Z, van den Braak MCT, Verrips GHW. An application of the Health Action Process Approach model to oral hygiene behaviour and dental plaque in adolescents with fixed orthodontic appliances. Int J Paediatr Dent. 2017 Nov;27(6):486-495. doi: 10.1111/ipd.12287. Epub 2017 Feb 7.</citation>
      <PMID>28176383</PMID>
    </reference>
    <reference>
      <citation>Scheerman JFM, van Meijel B, van Empelen P, Kramer GJC, Verrips GHW, Pakpour AH, Van den Braak MCT, van Loveren C. Study protocol of a randomized controlled trial to test the effect of a smartphone application on oral-health behavior and oral hygiene in adolescents with fixed orthodontic appliances. BMC Oral Health. 2018 Feb 7;18(1):19. doi: 10.1186/s12903-018-0475-9.</citation>
      <PMID>29415697</PMID>
    </reference>
    <reference>
      <citation>Rigau-Gay MM, Claver-Garrido E, Benet M, Lusilla-Palacios P, Ustrell-Torrent JM. Effectiveness of motivational interviewing to improve oral hygiene in orthodontic patients: A randomized controlled trial. J Health Psychol. 2020 Nov-Dec;25(13-14):2362-2373. doi: 10.1177/1359105318793719. Epub 2018 Sep 10.</citation>
      <PMID>30198774</PMID>
    </reference>
    <reference>
      <citation>Gao X, Lo EC, Kot SC, Chan KC. Motivational interviewing in improving oral health: a systematic review of randomized controlled trials. J Periodontol. 2014 Mar;85(3):426-37. doi: 10.1902/jop.2013.130205. Epub 2013 Jun 27.</citation>
      <PMID>23805818</PMID>
    </reference>
    <reference>
      <citation>Acharya S, Goyal A, Utreja AK, Mohanty U. Effect of three different motivational techniques on oral hygiene and gingival health of patients undergoing multibracketed orthodontics. Angle Orthod. 2011 Sep;81(5):884-8. doi: 10.2319/112210-680.1. Epub 2011 May 25.</citation>
      <PMID>21612316</PMID>
    </reference>
    <reference>
      <citation>Enaia M, Bock N, Ruf S. White-spot lesions during multibracket appliance treatment: A challenge for clinical excellence. Am J Orthod Dentofacial Orthop. 2011 Jul;140(1):e17-24. doi: 10.1016/j.ajodo.2010.12.016.</citation>
      <PMID>21724067</PMID>
    </reference>
    <reference>
      <citation>Ekstrand KR, Gimenez T, Ferreira FR, Mendes FM, Braga MM. The International Caries Detection and Assessment System - ICDAS: A Systematic Review. Caries Res. 2018;52(5):406-419. doi: 10.1159/000486429. Epub 2018 Mar 8.</citation>
      <PMID>29518788</PMID>
    </reference>
    <reference>
      <citation>Guarnizo-Herreno CC, Watt RG, Garzon-Orjuela N, Suarez-Zuniga E, Tsakos G. Health insurance and education: major contributors to oral health inequalities in Colombia. J Epidemiol Community Health. 2019 Aug;73(8):737-744. doi: 10.1136/jech-2018-212049. Epub 2019 May 16.</citation>
      <PMID>31097482</PMID>
    </reference>
    <reference>
      <citation>Marinho VC, Higgins JP, Sheiham A, Logan S. Fluoride toothpastes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2003;2003(1):CD002278. doi: 10.1002/14651858.CD002278.</citation>
      <PMID>12535435</PMID>
    </reference>
    <reference>
      <citation>Aljabaa A, McDonald F, Newton JT. A systematic review of randomized controlled trials of interventions to improve adherence among orthodontic patients aged 12 to 18. Angle Orthod. 2015 Mar;85(2):305-13. doi: 10.2319/031214-184.1. Epub 2014 Jul 21.</citation>
      <PMID>25045779</PMID>
    </reference>
    <reference>
      <citation>Gao X, Lo EC, McGrath C, Ho SM. Face-to-face individual counseling and online group motivational interviewing in improving oral health: study protocol for a randomized controlled trial. Trials. 2015 Sep 18;16:416. doi: 10.1186/s13063-015-0946-0.</citation>
      <PMID>26385340</PMID>
    </reference>
    <reference>
      <citation>Talic NF. Adverse effects of orthodontic treatment: A clinical perspective. Saudi Dent J. 2011 Apr;23(2):55-9. doi: 10.1016/j.sdentj.2011.01.003. Epub 2011 Jan 28.</citation>
      <PMID>24151415</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidad Nacional de Colombia</investigator_affiliation>
      <investigator_full_name>Adriana del Pilar Forero</investigator_full_name>
      <investigator_title>Associate professor, Department of Oral health, Orthodontic Sciences , National University of Colombia</investigator_title>
    </responsible_party>
    <keyword>Adolescent,Teenagers,Young Adult,Adult</keyword>
    <keyword>&quot;Motivational Interviewing&quot;[Mesh]</keyword>
    <keyword>&quot;Health Education, Dental&quot;[Mesh]</keyword>
    <keyword>&quot;Orthodontic Appliances&quot;[Mesh]</keyword>
    <keyword>&quot;Orthodontic Appliances, Fixed&quot;[Mesh]</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Caries</mesh_term>
      <mesh_term>Tooth Demineralization</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979805
  org study id: ECA 103-23
  nct id: NCT05979805
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Dental caries is classified by the World Health Organization (WHO) as an important public
        health problem due to its high prevalence and incidence worldwide despite the development of
        public policies to combat it. It is a chronic disease that has a severe impact in terms of
        pain and suffering, impairment of function and effect on quality of life. During orthodontic
        treatments, the most common adverse event is the appearance of dental caries lesions due to
        increased retention, change of dental biofilm composition or difficulty of removal with
        conventional oral hygiene techniques. Efforts to implement various conventional preventive
        interventions of self-care and education have not decreased its incidence, so it is necessary
        to implement motivational interventions to help adolescents and young adults to make positive
        changes in their oral health habits, which are constant and lasting and prevent and control
        caries.
  Dental caries is a multifactorial disease but the only necessary factor, although
        insufficient for its development, is bacterial biofilm; brackets significantly increase its
        retention and limit self- cleaning mechanisms, representing a challenge in clinical practice.
        Motivational interventions in oral health could be an alternative to generate behavioral
        changes in oral health and daily self-care routines that are more sustainable over time
        compared to conventional education models in patients with fixed orthodontic appliances.
  
        A controlled, randomized, parallel and pragmatic clinical study is proposed for the
        evaluation of the effect of conventional educational intervention and motivational
        interviewing in comparison with conventional educational interventions in the prevention of
        dental caries lesions. A sample size of 94 patients in total is proposed, distributed 47 in
        each arm of the study, with a follow-up of the cohort for six months. The baseline risk will
        be established before the placement of fixed appliances (T0), and a follow-up will be carried
        out during six months, with assessments in one (T1), three(T2) and six months (T3) after
        cementation, where the presence of caries and changes in risk variables, adverse events and
        adherence to conventional and motivational interventions, will be measured.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A controlled, randomized, parallel and pragmatic clinical study is proposed for the evaluation of the effect of conventional educational interventions and motivational interviewing in comparison with conventional educational interventions, in the prevention of dental caries lesions in 94 patients aged 13 to 44 years old, who will begin corrective orthodontic treatment with fixed appliances in the postgraduate clinics of Orthodontics and Maxillary Orthopedics of the National University of Colombia.
  primary purpose: Prevention
  masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  masking description: The examiner calibrated and certified in the International Caries Detection and Assessment System (ICDAS) visual diagnostic criteria for dental caries at T0, T1, T2 and T3 (primary outcome)
  The examiner calibrated in measurement of risk variables (secondary outcomes) like plaque index, habits of oral hygiene and habits in sugar consumption.
  Statistician
  measure: Changes in ICDAS score of the caries
  time frame: 6 months
  description: Change in incidence of caries on the vestibular surface by ICDAS in T0 (baseline),T1 (1 month),T2 (3 months) and T3 (6 months) will be censured when the patient presents the outcome, the study period ends (six months) or when the follow-up period finishes for a reason other than the event of interest being studied.
  measure: Change of Plaque index
  time frame: 6 months
  description: Changes in modification of the Silness and Löe index described by Williams at T0 (baseline), T1 (one month), T2 (three months) and T3 (six months) after the start of orthodontic treatment with fixed appliances.
  measure: Adverse events
  time frame: 6 months
  description: Measurement of possible adverse events during educational interventional at T0 (baseline), T1 (one month), T2 (three months) and T3 (six months) after the start of orthodontic treatment with fixed appliances.
  arm group label: Conventional Oral health Education
  arm group type: Active Comparator
  description: Conventional oral health education and nutritional guidelines prior to the placement of fixed appliances, by means of a 5-8 minute video and instructive brochure.
  arm group label: Motivational interviewing + Conventional Oral health Education
  arm group type: Experimental
  description: Include the conventional oral health education of the control group and a 30 minute motivational interviewing (MI)
  intervention type: Other
  intervention name: Conventional Educational interventions
  description: Conventional educational methods can be verbal, written or visual and can be combined for greater understanding and effectiveness in oral health and dietary routines. The education are imparted in the first appointment of the appliances cementation by a video and oral health instruction booklet and each patient receive an oral hygiene kit. This education is repeated in month 1 and 3 after appliances cementation.
  arm group label: Conventional Oral health Education
  arm group label: Motivational interviewing + Conventional Oral health Education
  intervention type: Behavioral
  intervention name: Motivational intervention
  description: In addition to the conventional educational method, a motivational interviewing (MI) by Miller and Rollnick of 30 minutes will be used, with an initial script according to the stage of change in each patient in T0. The reinforcements of motivational interviewing are in month one and three after the installation of the braces, they will have the same methodology but will be focused on the aspects that in the previous session or in the clinical assessment were detected as the most important deficiencies or risk factors for the patient.
  arm group label: Motivational interviewing + Conventional Oral health Education
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 44 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Adriana Forero Niño, DDs
  role: Principal Investigator
  affiliation: 111211
  last name: Adriana Forero Niño, DDs
  phone: (571) 3102416420
  email: apforeron@unal.edu.co
  last name: Jorge Rubio Romero, MD MSc
  phone: (571) 3165000
  phone ext: 15122
  email: jarubior@unal.edu.co
  citation: Sundararaj D, Venkatachalapathy S, Tandon A, Pereira A. Critical evaluation of incidence and prevalence of white spot lesions during fixed orthodontic appliance treatment: A meta-analysis. J Int Soc Prev Community Dent. 2015 Nov-Dec;5(6):433-9. doi: 10.4103/2231-0762.167719.
  PMID: 26759794
  citation: Shimpo Y, Nomura Y, Sekiya T, Arai C, Okada A, Sogabe K, Hanada N, Tomonari H. Effects of the Dental Caries Preventive Procedure on the White Spot Lesions during Orthodontic Treatment-An Open Label Randomized Controlled Trial. J Clin Med. 2022 Feb 6;11(3):854. doi: 10.3390/jcm11030854.
  PMID: 35160305
  citation: Martignon S, Ekstrand KR, Lemos MI, Lozano MP, Higuera C. Plaque, caries level and oral hygiene habits in young patients receiving orthodontic treatment. Community Dent Health. 2010 Sep;27(3):133-8.
  PMID: 21046903
  citation: Chapman JA, Roberts WE, Eckert GJ, Kula KS, Gonzalez-Cabezas C. Risk factors for incidence and severity of white spot lesions during treatment with fixed orthodontic appliances. Am J Orthod Dentofacial Orthop. 2010 Aug;138(2):188-94. doi: 10.1016/j.ajodo.2008.10.019.
  PMID: 20691360
  citation: Ogaard B, Rolla G, Arends J. Orthodontic appliances and enamel demineralization. Part 1. Lesion development. Am J Orthod Dentofacial Orthop. 1988 Jul;94(1):68-73. doi: 10.1016/0889-5406(88)90453-2.
  PMID: 3164585
  citation: Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.
  PMID: 21208070
  citation: Fejerskov O. Concepts of dental caries and their consequences for understanding the disease. Community Dent Oral Epidemiol. 1997 Feb;25(1):5-12. doi: 10.1111/j.1600-0528.1997.tb00894.x.
  PMID: 9088687
  citation: Scheerman JFM, van Empelen P, van Loveren C, Pakpour AH, van Meijel B, Gholami M, Mierzaie Z, van den Braak MCT, Verrips GHW. An application of the Health Action Process Approach model to oral hygiene behaviour and dental plaque in adolescents with fixed orthodontic appliances. Int J Paediatr Dent. 2017 Nov;27(6):486-495. doi: 10.1111/ipd.12287. Epub 2017 Feb 7.
  PMID: 28176383
  citation: Scheerman JFM, van Meijel B, van Empelen P, Kramer GJC, Verrips GHW, Pakpour AH, Van den Braak MCT, van Loveren C. Study protocol of a randomized controlled trial to test the effect of a smartphone application on oral-health behavior and oral hygiene in adolescents with fixed orthodontic appliances. BMC Oral Health. 2018 Feb 7;18(1):19. doi: 10.1186/s12903-018-0475-9.
  PMID: 29415697
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  responsible party type: Principal Investigator
  investigator affiliation: Universidad Nacional de Colombia
  investigator full name: Adriana del Pilar Forero
  investigator title: Associate professor, Department of Oral health, Orthodontic Sciences , National University of Colombia
  mesh term: Dental Caries
  mesh term: Tooth Demineralization
  sharing ipd: No