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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Поведенческое 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

Первичные конечные точки

• Changes in ICDAS score of the caries [Срок оценки: 6 months]
• Evaluation of gingivitis [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Change of Plaque index [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Колумбия · 1 центр

• Universidad Nacional de Colombia — Bogotá

Публикации

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Идентификаторы

NCT: NCT05979805 · ECA 103-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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