- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03723174
Impact of an Educational Program on Gingival Status and Oral Health Related Quality of Life
July 27, 2021 updated by: Fayrouz Saber, Cairo University
Impact of an Educational Program on Oral Health Related Quality of Life in a Group of 11 to 14 Years Old Egyptian Children: Before and After Study.
This research targets the evaluation of the impact of oral health educational programs on the gingival status and oral health related quality of life in early adolescence of the Egyptian population.
Each participant will benefit from the education of the proper oral hygiene practices under the supervision and follow up of the investigator in addition to the potential improvement of his/ her oral health related quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to improve the gingival status and oral health related quality of life in the Egyptian population's early adolescence. The intervention is an Oral health educational program based on the following:
- Tooth brushing: the modified bass technique is the method of choice the skill will be taught using a video followed by a model demonstration then a supervised brushing session done by the participants.
- Dietary recommendations and importance of visiting the dentist will be introduced in the form of power point presentation that will be set according to the American Academy of Pediatric Dentistry (AAPD).
- Participant will be asked to come for 4 visits one for base line data collection and administration of the intervention and another 3 follow up visits once per month.
Study Type
Observational
Enrollment (Actual)
91
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
-
-
-
Giza, Egypt, 12676
- New Giza 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
11 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children aged from 11 to 14 years old seeking dental care at the educational hospital, Department of Pediatric Dentistry and Dental Public Health, School of Dentistry New Giza University.
Description
Inclusion Criteria:
- Patients aged from 11-14 years old
- No reported systemic disease
- No administration of antibiotics in the last month
- No fixed or removable appliance
- Absence of acute phase of any oral disease
Exclusion Criteria:
- Patient refuses to participate in the study
- patient fails to attend follow up sessions
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Single Arm
baseline data will be calculated before the oral health educational program using gingival index and after 3 months from the intervention
|
proper introduction to brushing techniques, dietary recommendations and importance of visiting the dentist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short form Child perception questionnaire 11-14
Time Frame: 3 months
|
assessment of Oral symptoms, functional limitations, emotional and social well being.
each domain scores from 0-20 where 20 means the worst quality of life in each domain.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Photographic evaluation and interpretation using Adobe Photoshop Creative Cloud 2021
Time Frame: 3 months
|
assessment of Swelling of gingiva red color characteristics using number of red pixels
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Manal Al Sayed, PhD, PROFESSOR
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bhardwaj VK, Sharma KR, Luthra RP, Jhingta P, Sharma D, Justa A. Impact of school-based oral health education program on oral health of 12 and 15 years old school children. J Educ Health Promot. 2013 Jul 31;2:33. doi: 10.4103/2277-9531.115820. eCollection 2013.
- Smith RN, Lath DL, Rawlinson A, Karmo M, Brook AH. Gingival inflammation assessment by image analysis: measurement and validation. Int J Dent Hyg. 2008 May;6(2):137-42. doi: 10.1111/j.1601-5037.2008.00294.x.
- Mostafa B, El-Refai I. Prevalence of Plaque-Induced Gingivitis in a Sample of the Adult Egyptian Population. Open Access Maced J Med Sci. 2018 Mar 10;6(3):554-558. doi: 10.3889/oamjms.2018.131. eCollection 2018 Mar 15.
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)
November 1, 2020
Primary Completion (Actual)
March 20, 2021
Study Completion (Actual)
May 30, 2021
Study Registration Dates
First Submitted
October 25, 2018
First Submitted That Met QC Criteria
October 26, 2018
First Posted (Actual)
October 29, 2018
Study Record Updates
Last Update Posted (Actual)
August 2, 2021
Last Update Submitted That Met QC Criteria
July 27, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- fay
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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