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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05979805
Study type Interventional
Source Universidad Nacional de Colombia
Contact Adriana Forero Niño, DDs
Phone (571) 3102416420
Email apforeron@unal.edu.co
Status Not yet recruiting
Phase N/A
Start date March 15, 2024
Completion date April 20, 2025

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