Effectiveness of Educational Interventions in the Prevention of Caries in Patients With Orthodontics

Sponsor
Universidad Nacional de Colombia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05979805
Collaborator
(none)
94
2
13.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Conventional Educational interventions
  • Behavioral: Motivational intervention
N/A

Detailed 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

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A controlled, randomized, parallel and pragmatic clinical study 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 in 94 patients aged 13 to 44 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.A controlled, randomized, parallel and pragmatic clinical study 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 in 94 patients aged 13 to 44 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.
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The examiner calibrated and certified in the International Caries Detection and Assessment System (ICDAS) visual diagnostic criteria for dental caries at T0, T1, T2 and T3 (primary outcome) The examiner calibrated in measurement of risk variables (secondary outcomes) like plaque index, habits of oral hygiene and habits in sugar consumption. Statistician
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Jul 20, 2024
Anticipated Study Completion Date :
Sep 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conventional Oral health Education

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.

Other: 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.

Experimental: Motivational interviewing + Conventional Oral health Education

Include the conventional oral health education of the control group and a 30 minute motivational interviewing (MI)

Other: 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.

Behavioral: 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 deficiencies or risk factors for the patient.

Outcome Measures

Primary Outcome Measures

  1. Changes in ICDAS score of the caries [6 months]

    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.

Secondary Outcome Measures

  1. 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.

Other Outcome Measures

  1. Adverse events [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 44 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universidad Nacional de Colombia

Investigators

  • Principal Investigator: Adriana Forero Niño, DDs, 111211

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Adriana del Pilar Forero, Associate professor, Department of Oral health, Orthodontic Sciences , National University of Colombia, Universidad Nacional de Colombia
ClinicalTrials.gov Identifier:
NCT05979805
Other Study ID Numbers:
  • ECA 103-23
First Posted:
Aug 7, 2023
Last Update Posted:
Aug 7, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Adriana del Pilar Forero, Associate professor, Department of Oral health, Orthodontic Sciences , National University of Colombia, Universidad Nacional de Colombia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 7, 2023