Effectiveness of Two Health Education Interventions in the Prevention of Caries and Gingivitis in Orthodontic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional Educational interventions, Motivational intervention.
- Who it may be relevant to
- Registry conditions: Dental Caries, Tooth Demineralization, Gingivitis. Basic parameters: 13 years — 28 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Colombia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Motivational Interviewing and Conventional Oral Health Education (OHEc) Versus OHEc in the Prevention and Control of Dental Caries and Gingivitis in Subjects With Fixed Orthodontic Appliances. A Randomized Controlled Trial
Overview
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.
Detailed description
Dental caries and gingivitis are multifactorial diseases, however the only necessary factor, although insufficient for their 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 randomized controlled clinical trial open to subjects and single-blinded (investigators) of parallel groups is proposed for the evaluation of the effect of motivational interviewing combined with conventional oral health education (OHEc) versus OHEc, in the prevention of dental caries lesions and gingivitis. 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 gingivitis, caries and changes in risk variables, adverse events and adherence to conventional and motivational interventions, will be measured.
Interventions
- Other Conventional Educational interventions
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. - Behavioral Motivational intervention
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 defici
Primary outcome measures
- Changes in ICDAS score of the caries [Time frame: 6 months]
- Evaluation of gingivitis [Time frame: 6 months]
Secondary outcome measures (1)
- Change of Plaque index [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Patients enrolled in the different orthodontic postgraduate clinics of the National University of Colombia who requires treatment with fixed orthodontic appliances
- 13 years old up to 28 years of age.
- Willingness to participate in the study and signature of the informed consent form.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Colombia · 1 center
- Universidad Nacional de Colombia — Bogotá
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT05979805 · ECA 103-23