Impact of an Educational Program on Gingival Status and Oral Health Related Quality of Life

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03723174
Collaborator
(none)
91
Enrollment
1
Location
6.9
Actual Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Oral Health Educational Program

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
91 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
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.
Actual Study Start Date :
Nov 1, 2020
Actual Primary Completion Date :
Mar 20, 2021
Actual Study Completion Date :
May 30, 2021

Arms and Interventions

ArmIntervention/Treatment
Single Arm

baseline data will be calculated before the oral health educational program using gingival index and after 3 months from the intervention

Behavioral: Oral Health Educational Program
proper introduction to brushing techniques, dietary recommendations and importance of visiting the dentist

Outcome Measures

Primary Outcome Measures

  1. Short form Child perception questionnaire 11-14 [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.

Secondary Outcome Measures

  1. Photographic evaluation and interpretation using Adobe Photoshop Creative Cloud 2021 [3 months]

    assessment of Swelling of gingiva red color characteristics using number of red pixels

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1New Giza UniversityGizaEgypt12676

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: Manal Al Sayed, PhD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fayrouz Saber, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT03723174
Other Study ID Numbers:
  • fay
First Posted:
Oct 29, 2018
Last Update Posted:
Aug 2, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2021