NCT03723174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
2 years until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

October 25, 2018

Last Update Submit

July 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Short form Child perception questionnaire 11-14

    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 Outcomes (1)

  • Photographic evaluation and interpretation using Adobe Photoshop Creative Cloud 2021

    3 months

Study Arms (1)

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

Interventions

proper introduction to brushing techniques, dietary recommendations and importance of visiting the dentist

Single Arm

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patient refuses to participate in the study
  • patient fails to attend follow up sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Giza University

Giza, 12676, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 24083283BACKGROUND
  • 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.

    PMID: 18412727BACKGROUND
  • 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.

MeSH Terms

Conditions

Gingival DiseasesMouth Diseases

Condition Hierarchy (Ancestors)

Periodontal DiseasesStomatognathic Diseases

Study Officials

  • Manal Al Sayed, PhD

    Professor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 29, 2018

Study Start

November 1, 2020

Primary Completion

March 20, 2021

Study Completion

May 30, 2021

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations