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

Primary Purpose

Dental Caries, Tooth Demineralization

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional Educational interventions
Motivational intervention
Sponsored by
Universidad Nacional de Colombia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Adolescent,Teenagers,Young Adult,Adult, "Motivational Interviewing"[Mesh], "Health Education, Dental"[Mesh], "Orthodontic Appliances"[Mesh], "Orthodontic Appliances, Fixed"[Mesh]

Eligibility Criteria

13 Years - 44 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conventional Oral health Education

    Motivational interviewing + Conventional Oral health Education

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    July 12, 2023
    Last Updated
    August 3, 2023
    Sponsor
    Universidad Nacional de Colombia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05979805
    Brief Title
    Effectiveness of Educational Interventions in the Prevention of Caries in Patients With Orthodontics
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2023 (Anticipated)
    Primary Completion Date
    July 20, 2024 (Anticipated)
    Study Completion Date
    September 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Nacional de Colombia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries, Tooth Demineralization
    Keywords
    Adolescent,Teenagers,Young Adult,Adult, "Motivational Interviewing"[Mesh], "Health Education, Dental"[Mesh], "Orthodontic Appliances"[Mesh], "Orthodontic Appliances, Fixed"[Mesh]

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Care ProviderInvestigatorOutcomes 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
    Allocation
    Randomized
    Enrollment
    94 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional Oral health Education
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Motivational interviewing + Conventional Oral health Education
    Arm Type
    Experimental
    Arm Description
    Include the conventional oral health education of the control group and a 30 minute motivational interviewing (MI)
    Intervention Type
    Other
    Intervention Name(s)
    Conventional Educational interventions
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in ICDAS score of the caries
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change of Plaque index
    Description
    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.
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Adverse events
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adriana Forero Niño, DDs
    Phone
    (571) 3102416420
    Email
    apforeron@unal.edu.co
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jorge Rubio Romero, MD MSc
    Phone
    (571) 3165000
    Ext
    15122
    Email
    jarubior@unal.edu.co
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adriana Forero Niño, DDs
    Organizational Affiliation
    111211
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Effectiveness of Educational Interventions in the Prevention of Caries in Patients With Orthodontics

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