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

Not Applicable

Recruiting

• Conditions: Dental Caries; Tooth Demineralization; Gingivitis
• Interventions: Other: Conventional Educational interventions; Behavioral: Motivational intervention

• Registration Number: NCT05979805
• Lead Sponsor: Universidad Nacional de Colombia

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-07
• Study Start: 2024-04-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-15
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-12-20
• Study Completion: 2026-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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 28 years of age.
• Willingness to participate in the study and signature of the informed consent form.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motivational interviewing + Conventional Oral health Education	Conventional Educational interventions	Include the conventional oral health education of the control group and a 30 minute motivational interviewing (MI)
Motivational interviewing + Conventional Oral health Education	Motivational intervention	Include the conventional oral health education of the control group and a 30 minute motivational interviewing (MI)
Conventional Oral health Education	Conventional Educational interventions	Conventional oral health education and nutritional guidelines prior to the placement of fixed appliances, by means of a 5-8 minute video and instructive brochure.

Primary Outcome Measures

Name	Time	Method
Changes in ICDAS score of the caries	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.
Evaluation of gingivitis	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.

Secondary Outcome Measures

Name	Time	Method
Change of Plaque index	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.

Trial Locations

Locations (1)

Universidad Nacional de Colombia; 🇨🇴 Bogotá, Colombia