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

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:

  1. Patients aged from 11-14 years old
  2. No reported systemic disease
  3. No administration of antibiotics in the last month
  4. No fixed or removable appliance
  5. Absence of acute phase of any oral disease

Exclusion Criteria:

  1. Patient refuses to participate in the study
  2. 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.

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.

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

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.

Clinical Trials on Oral Disease

Clinical Trials on Oral Health Educational Program

Subscribe