Universidad Nacional de Colombia
Bogotá, 111321, Colombia
Location status: Recruiting
NCT Number: NCT05979805
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.
Interested in participating?
Request Info13 year–28 year
All sexes
Interventional
Not applicable
Bogotá, 111321, Colombia
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Contact information is provided by the study sponsor or research team.
Universidad Nacional de Colombia
Other
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
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