Dental Caries Clinical Trial
Official title:
Effectiveness of Motivational Interviewing and Conventional Interventions in the Prevention of Vestibular Caries in Patients With Fixed Orthodontic Appliances: a Randomized Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 94 |
Est. completion date | April 20, 2025 |
Est. primary completion date | December 20, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 28 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universidad Nacional de Colombia |
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | 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. | 6 months | |
Primary | 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 | 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 |
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