Effectiveness of Educational Interventions in the Prevention of Caries in Patients With Orthodontics

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Motivational Interviewing and Conventional Interventions in the Prevention of Vestibular Caries in Patients With Fixed Orthodontic Appliances: a Randomized Clinical Trial

Conditions
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Dental Caries, Tooth Demineralization

Intervention / Treatment
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* Other: Conventional Educational interventions
* Behavioral: Motivational intervention


Participation Criteria
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Eligibility Criteria
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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 44 years of age. Exclusion Criteria: Patients with untreated caries lesions Patients with periodontal diseases Previous orthodontics treatments Severe fluorosis or enamel abnormalities. Medical compromise Medical treatments generating hyposalivation or gingival enlargement, Craniomaxillary anomalies Cognitive or motor disability Pregnancy.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Oral health Education<br>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<br>* 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.<br>|
| Experimental: Motivational interviewing + Conventional Oral health Education<br>Include the conventional oral health education of the control group and a 30 minute motivational interviewing (MI) | Other: Conventional Educational interventions<br>* 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.<br>Behavioral: Motivational intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ICDAS score of the caries | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Plaque index | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent,Teenagers,Young Adult,Adult, Motivational Interviewing[Mesh], Health Education, Dental[Mesh], Orthodontic Appliances[Mesh], Orthodontic Appliances, Fixed[Mesh]