- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07307313
Effectiveness of Motivational Interviewing in Promoting Oral Health Among Children
Effectiveness of Motivational Interviewing Versus Traditional Patient Education in Promoting Oral Health Among Children
The goal of this clinical study is to compare the effect of motivational interviewing (MI) and traditional patient education methods in improving oral hygiene (plaque score and bleeding score) among young children 8-10. It will also assess the demographic (age and sex) and socioeconomic indicators' effect on oral hygiene (plaque score and bleeding score) after intervention.
The main questions this study aims to answer are:
- Is MI significantly more effective in improving oral health (plaque score, bleeding score) among children when compared to traditional patient education methods?
- Are there specific demographic or contextual factors (e.g., age, socioeconomic status, baseline oral health status) that influence the effectiveness of MI in promoting oral health among children when compared to traditional patient education methods?
Participants will be randomly assigned to three groups to receive oral hygiene instructions: verbal and written, video, and motivational interviewing.
Have their oral hygiene assessed using the plaque index and bleeding index before the intervention and after a follow-up period of 1 month.
Study Overview
Status
Conditions
Detailed Description
This clinical study aims to compare the effect of motivational interviewing (MI) and traditional patient education methods in improving oral hygiene (plaque score and bleeding score) among young children aged 8-10. The study is a randomized clinical trial that will be conducted among healthy pediatric patients attending the pediatric dentistry clinics at the University of Jordan Hospital.
Patients who meet the inclusion criteria and give consent will be randomly assigned to three groups:
- Verbal and written instructions group: Basic oral hygiene instruction will be given to this group on a model of the mouth and then supported by written instructions.
- Video monitored (VIDEO) group: Uploaded from the National Health Service (NHS) website and translated to the patient's mother tongue (Arabic).
- Motivational interviewing (MI) group: The participants will join the motivation sessions one-to-one, face-to-face, with the primary researcher, who will be trained and calibrated to provide MI and take sessions with qualified psychologists.
Oral hygiene will be assessed using two parameters:
Plaque index scoring: 0/1 Bleeding on probing score: 0/1 Each patient will be examined twice: the first time is before the intervention, and the second is after a follow-up period of 1 month.
The study will also investigate the influence of age, sex, and socioeconomic status on oral hygiene improvement.
The findings of this research aim to contribute to the growing body of literature on MI and inform public health strategies aimed at reducing the global burden of childhood dental diseases.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amman, Jordan
- Lamis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children who are medically healthy
- Children with normal manual dexterity
- Children whose parents/guardians provide informed consent
- Children not currently receiving orthodontic therapy
- Children who do not require periodontal specialty care
- Children with normal occlusion or mild, non-treatment-requiring malocclusion
Exclusion Criteria:
- Children with systematic, or syndromic disease
- Children with special health care needs
- Children with poor manual dexterity
- Children with negative consents.
- Children with current orthodontic therapy
- Children with chronic diseases.
- Children on medications that may cause drug-induced gingivitis.
- Children who attend periodontal clinics.
- Children with malocclusion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video
|
A video about oral hygiene instructions uploaded from NHS and translated for the mother tongue language of the participants
|
|
Experimental: Motivational interviewing
|
Brief motivational interviewing session for each patient for around 20-30 minutes
|
|
Experimental: Written and verbal instructions
|
Basic oral hygiene instruction will be given verbally and then supported by written instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque index
Time Frame: From enrollment to the 4-week follow-up appointment
|
The primary researcher will document the plaque index for each patient prior to the intervention and after the follow-up appointment after 1 month using Plaque Control Index scoring
|
From enrollment to the 4-week follow-up appointment
|
|
Bleeding index
Time Frame: From enrollment to the 4-week follow-up appointment
|
The primary researcher will document the bleeding index for each patient prior to the intervention and during every follow-up appointment using Gingival Bleeding Index (GBI)
|
From enrollment to the 4-week follow-up appointment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UJordanLamis3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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