NCT07771634

Brief Summary

Background: Orphan children are at higher risk of developing oral diseases, compared to non-orphans. They also face various emotional, social, and psychological distresses which affect their general as well as oral health. Aim: To evaluate the effectiveness of three methods of dental health education; namely peer group and game-based health education methods on oral hygiene behavior, oral health care self- efficacy and self-esteem level of a group of institutionalized orphans in Alexandria, Egypt, as compared to conventional health education. Materials and methods: A three-arm randomized controlled clinical trial was compared between peer group based dental health education, game-based dental health education, and conventional dental health education. The study recruited 264 Orphans from non-governmental orphanages in Alexandria, Egypt. Apparently healthy orphans between 7 and 12 years old whose responsible guardians gave consent to allow them to participate in the study will be included. The primary outcome was the improvement in oral hygiene behavior measured by changes in OHI-S and gingival index and the secondary outcome was the change in orphans' self-esteem measured by the Child version of Rosenberg Self-Esteem Scale and the change in orphans' oral health care self-efficacy measured by oral heath behavior self-efficacy questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

December 14, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 12, 2026

Last Update Submit

August 15, 2026

Conditions

Keywords

Gingival indexOral Hygiene Index-Simplified (OHI-S)Self-EfficacySelf-EsteemOrphanagesDental Health Education

Outcome Measures

Primary Outcomes (2)

  • Change in Oral Hygiene Status as Measured by the Simplified Oral Hygiene Index (OHI-S) Score

    Evaluated using the Simplified Oral Hygiene Index (OHI-S). Scores range from 0.0 to 6.0 on a continuous scale, calculated as the sum of the Debris Index and Calculus Index. Lower scores indicate better oral hygiene

    Baseline, 1 month, 3 months, and 6 months

  • Change in Gingival Health as Measured by the Loe and Silness Gingival Index (GI) Score

    Evaluated using the Loe and Silness Gingival Index (GI). Scores range from 0 to 3 on a continuous scale, where 0 represents normal/healthy gingiva and 3 represents severe inflammation. Lower scores indicate better gingival health.

    Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (2)

  • Change in Oral Health Care Self-Efficacy Score Assessed via the Adapted 3-Point Oral Health Behavior Self-Efficacy Questionnaire

    Baseline, 3 months, and 6 months

  • Change in Self-Esteem Score Assessed via the Adapted Binary Child version of Rosenberg Self-Esteem Scale

    Baseline, 3 months, and 6 months

Other Outcomes (1)

  • Change in Oral Health Behaviors (Brushing Frequency and Dental Visits) Assessed via the WHO Child Oral Health Questionnaire

    Baseline, 1 month, 3 months, and 6 months

Study Arms (3)

Conventional dental health education group

ACTIVE COMPARATOR

Delivered through a 30 minute session given to orphans control group.

Behavioral: Conventional dental health education

Game based dental health education group

EXPERIMENTAL

oral health education was given- within 2 days- through power point presentation -including the same information described for the first group- followed by the educational games where children were divided into groups of fives and there was a quiz at the end of the session

Behavioral: Game based dental health education

Peer-group based dental health education group

EXPERIMENTAL

from every 10 orphans, two orphans - who were willing to participate- were chosen. The researcher provided health education to peer group within a 2-days training workshop

Behavioral: Peer-group based dental health education

Interventions

It was delivered through a 30 minute session given to orphans control group. Children were given information about oral anatomy, causes of dental caries, role of plaque, diet / frequency of sweet snacks, brushing technique, toothpaste and fluoride using power point presentation, tooth brushing demonstration model, posters and other visual aids. Ten minutes were given to answer children's questions

Conventional dental health education group

Crosswords game: consists of questions regarding dental caries and oral hygiene arranged horizontally and vertically. * Connect the dots: Children were instructed to connect the dots between two alphabets and read out the oral hygiene instructions written along with it. When the dots are connected children will be able to see a happy 'Bright Smile' tooth. This helped the children to realize that following the set of instructions will give them a bright smile. * Good for my teeth coloring sheets: child was instructed to color things that are good for teeth and put (x) on things that are bad for teeth. * The truth about teeth sheets: it consists of set of sentences about teeth, the child was instructed to read the sentence and color in the teeth to show if the sentence is true or false.

Game based dental health education group

from every 10 orphans, two orphans - who were willing to participate- will be chosen. The researcher provided health education to peer group within a 2-days training workshop. Each training session constituted of 20 minutes, the first session focused on oral anatomy, the value of teeth, diet and nutrition. The second session will focus on causes of dental caries, effective use of fluorides and particular emphasis will be given to oral hygiene procedures totaling the same information delivered in the two previous methods. Power point presentation, models and posters will be used to make sessions more interactive. After completion of training sessions, orphans in turn provided the same education to their peer group orphans using the same educational aids, supervised by the investigator. The orphans took part in daily oral hygiene instructions which was supervised by the peer group.

Peer-group based dental health education group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 7 and 12 years (to assess oral health of young children and enhance their self-efficacy and self-esteem and to avoid psychological problems of adolescent age group related to addiction and sexual abuse)
  • Healthy children (as reported in their records) with no history of chronic illness or medication
  • Orphans whose responsible guardian give consent to allow them to participate in the study.

You may not qualify if:

  • Children with enamel and/or dentine developmental defects which may affect their caries experience.
  • Special needs orphans with systemic, mental or other behavioral disorders or medically compromised conditions.
  • Orphans undergoing dental treatment which may affect indices score

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Social affairs

Alexandria, 21523, Egypt

Location

MeSH Terms

Conditions

Dental PlaqueGingival Diseases

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Hala Amer, Professor

    Alexandria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Researcher, Department of Dental Public Health

Study Record Dates

First Submitted

August 12, 2026

First Posted

August 18, 2026

Study Start

December 14, 2025

Primary Completion

July 17, 2026

Study Completion

July 27, 2026

Last Updated

August 18, 2026

Record last verified: 2026-08

Locations