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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
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.
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.
Age
13 - 28 years
Sex
ALL
Healthy Volunteers
Yes
Universidad Nacional de Colombia
Bogotá, Colombia
Start Date
April 15, 2024
Primary Completion Date
December 20, 2025
Completion Date
April 20, 2026
Last Updated
March 19, 2025
94
ESTIMATED participants
Conventional Educational interventions
OTHER
Motivational intervention
BEHAVIORAL
Lead Sponsor
Universidad Nacional de Colombia
NCT06430957
NCT05813236
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