- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06449950
The Effects of Different Oral Hygiene Instructions
June 4, 2024 updated by: Akif Demirel, Ankara University
The Evaluation of the Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomized Clinical Trial
The aim of this study is to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups.
202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol.
Before oral hygiene instructions, baseline oral g of all patients were determined using Simplified Oral Hygiene Index (OHI-S).
Within each age group, approximately half of the participants randomly assigned to verbal (n=50 for 6-9 ages, n=51 for 10-12 ages) and video-based OHI (n=51 for 6-9 ages, n=50 for 10-12 ages).
Patients were re-called for after 30 days and final OHI-S scores were recorded.
Study Overview
Status
Completed
Detailed Description
In pediatric dentistry, preventive dental approaches are essential in providing sustainable oral health of children.
Despite all the preventive applications, dental caries is still an important public health problem affecting preschool and school children.
Oral hygiene education has an important role on the dental health services.
This aims to increase awareness of oral health, provide information about it and encourage individuals to maintain oral health.
Based on, the current study aims to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups.
202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol.
Before oral hygiene instructions, baseline oral g of all patients were determined using Simplified Oral Hygiene Index (OHI-S).
Within each age group, approximately half of the participants randomly assigned to verbal (n=50 for 6-9 ages, n=51 for 10-12 ages) and video-based OHI (n=51 for 6-9 ages, n=50 for 10-12 ages).
Patients were re-called for after 30 days and final OHI-S scores were recorded.
Data were analysed with Shapiro-Wilk, Mann-Whitney U and Wilcoxon Signed Rank tests.
Statistical significance level was considered as 5%.
Study Type
Interventional
Enrollment (Actual)
202
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06560
- Ankara University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Children aged 6-9 years or 10-12 years
- Children who were medically free of chronic/systemic conditions
- Patients without physical or mental disabilities or syndromes
- Patients without motor dysfunction diseases
- Patients whose permanent central incisor and permanent first molar teeth had erupted and had not been extracted for any reason
Exclusion Criteria:
- Children aged <6 or >12 years
- Children with chronic/systemic conditions
- Patients with physical or mental disabilities or syndromes
- Patients with motor dysfunction diseases
- Patients whose permanent central incisor and permanent first molar teeth had not erupted
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Verbal Oral Hygiene Instruction Group
Verbal oral hygiene instructions were given to the pediatric patients by the instructor using the Bass brushing technique without any training model or visual aids, only with the verbal instructions.
|
OHI-S index scores of patients who received verbal oral hygiene education were measured at baseline and final (in post-education).
|
|
Experimental: Video-Based Oral Hygiene Instruction Group
The video-based oral hygiene instructions to be delivered to the paediatric dental participants were given by watching a pre-prepared video tape on a tooth and jaw model, using the instructions specified in the verbal education.
|
OHI-S index scores of patients who received video-based oral hygiene education were measured at baseline and final (in post-education).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simplified Oral Hygiene Index (OHI-S) Scoring
Time Frame: 30 days
|
In the present study, 30 days after verbal and video-based oral hygiene instructions were given to patients, oral hygiene status was similarly determined and recorded using OHI-S index method (OHI-S final scores).
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2023
Primary Completion (Actual)
September 12, 2023
Study Completion (Actual)
September 12, 2023
Study Registration Dates
First Submitted
June 4, 2024
First Submitted That Met QC Criteria
June 4, 2024
First Posted (Actual)
June 10, 2024
Study Record Updates
Last Update Posted (Actual)
June 10, 2024
Last Update Submitted That Met QC Criteria
June 4, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 11/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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