Clinical trial NCT05979805: Effectiveness of Two Health Education Interventions in the Prevention of Caries and Gingivitis in Orthodontic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries
Tooth Demineralization
Gingivitis
Keywords: Adolescent,Teenagers,Young Adult,Adult
&#34;Motivational Interviewing&#34;[Mesh]
&#34;Health Education, Dental&#34;[Mesh]
&#34;Orthodontic Appliances&#34;[Mesh]
&#34;Orthodontic Appliances, Fixed&#34;[Mesh]
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 94
Sex: ALL
Minimum age (years): 13
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical trial open to subjects and single-blinded (investigators) of parallel groups is proposed for the evaluation of the effect of conventional educational interventions and motivational interviewing in comparison with conventional educational interventions, in the prevention of dental caries lesions and gingivitis in 94 patients aged 13 to 28 years old, who will begin corrective orthodontic treatment with fixed appliances in the postgraduate clinics of Orthodontics and Maxillary Orthopedics of the National University of Colombia.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in ICDAS score of the caries
timeFrame: 6 months
measure: Evaluation of gingivitis
timeFrame: 6 months
Secondary outcomes:
measure: Change of Plaque index
timeFrame: 6 months
Other outcomes:
measure: Adverse events
timeFrame: 6 months
Locations:
city: Bogotá
country: Colombia
facility: Universidad Nacional de Colombia
Study officials:
affiliation: 111211
name: Adriana Forero Niño, DDs
role: PRINCIPAL_INVESTIGATOR
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