Effectiveness of Two Health Education Interventions in the Prevention of Caries and Gingivitis in Orthodontic Patients

NCT05979805 | Recruiting DMC

• 1 other identifier: ECA 103-23
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries and gingivitis are classified by the World Health Organization (WHO) as an important public health problem due to their high prevalence and incidence worldwide despite the development of public policies to combat them. They are chronic diseases that have 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 and gingivitis due to increased retention and 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 their 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 gingivitis and caries.

Conditions

Dental Caries; Tooth Demineralization; Gingivitis

Keywords

Adolescent,Teenagers,Young Adult,Adult; "Motivational Interviewing"[Mesh]; "Health Education, Dental"[Mesh]; "Orthodontic Appliances"[Mesh]; "Orthodontic Appliances, Fixed"[Mesh]

Outcome Measures

Primary Outcomes (2)

• Changes in ICDAS score of the caries

  Change in incidence of caries on the vestibular and proximal surfaces by ICDAS and radiographic 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.

  6 months

• Evaluation of gingivitis

  Changes in modification of the Silness and Löe gingival 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.

  6 months

Secondary Outcomes (1)

• Change of Plaque index

  6 months

Other Outcomes (1)

• Adverse events

  6 months

Study Arms (2)

Conventional Oral health Education

ACTIVE COMPARATOR

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.

Other: Conventional Educational interventions

Motivational interviewing + Conventional Oral health Education

EXPERIMENTAL

Include the conventional oral health education of the control group and a 30 minute motivational interviewing (MI)

Other: Conventional Educational interventions; Behavioral: Motivational intervention

Interventions

Conventional Educational interventions OTHER

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.

Conventional Oral health Education; Motivational interviewing + Conventional Oral health Education

Motivational intervention BEHAVIORAL

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.

Motivational interviewing + Conventional Oral health Education

Eligibility Criteria

• Age: 13 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients enrolled in the different orthodontic postgraduate clinics of the National University of Colombia who requires treatment with fixed orthodontic appliances
• years old up to 28 years of age.
• Willingness to participate in the study and signature of the informed consent form.

You may not qualify if:

• Patients with untreated caries lesions
• Patients with periodontal diseases or experience
• Previous orthodontics treatments
• Severe fluorosis or enamel abnormalities.
• Medical compromise or treatments generating hyposalivation or gingival enlargement
• Craniomaxillary anomalies
• Cognitive or motor disability
• Pregnancy.
• Dependence to alcohol, nicotine or psychoactive substances

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Universidad Nacional de Colombia

Bogotá, 111321, Colombia

RECRUITING

Related Publications (19)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 30198774 BACKGROUND

• 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.

  PMID: 23805818 BACKGROUND

• 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.

  PMID: 21612316 BACKGROUND

• 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.

  PMID: 21724067 BACKGROUND

• 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.

  PMID: 29518788 BACKGROUND

• 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.

  PMID: 31097482 BACKGROUND

• 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.

  PMID: 12535435 BACKGROUND

• 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.

  PMID: 25045779 BACKGROUND

• 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.

  PMID: 26385340 BACKGROUND

• 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.

  PMID: 24151415 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Tooth Demineralization; Gingivitis

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Adriana Forero Niño, DDs

  111211

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Forero Niño, DDs

CONTACT

(571) 3102416420; apforeron@unal.edu.co

Jorge Rubio Romero, MD MSc

CONTACT

(571) 3165000; jarubior@unal.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The randomization tool of the RedCap (Research Electronic Data Capture) platform will be used. The randomizing will be performed by an independent investigator who has no contact or access to the information of the subjects, ensuring that the allocation will be blinded for the rest of the investigators. The patient will know the assigned group when he or she is scheduled to the motivational intervention, thus the study will be open to the subjects. The investigator who performs motivational and usual intervention is not blinded because once the patient is summoned for the application of motivational intervention, he/she will know the assigned group. Investigators who perform clinical measurements and indexes will remain blinded throughout the study by means of restricted access to the randomization instrument and general data recording of the study. The statistical data evaluator will be unaware of the allocation of the interventions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Department of Oral health, Orthodontic Sciences , National University of Colombia

Model Details: A randomized controlled clinical trial open to subjects and single-blinded (investigators) of parallel groups 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 and gingivitis in 94 patients aged 13 to 28 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.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 7, 2023
• Study Start: April 15, 2024
• Primary Completion: December 20, 2025
• Study Completion: April 20, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)