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CompletedNCT07771634Updated Aug 18, 2026

Effectiveness of Dental Health Education Methods on Oral Hygiene, Oral Health Care Self-Efficacy and Self-Esteem of Young Orphans

An interventional study of Conventional dental health education and Game based dental health education in Dental Plaque, Gingival Diseases and Oral Health, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Alexandria University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2025, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dental Plaque
  • Gingival Diseases
  • Oral Health
  • Self Efficacy
  • Self Concept

Keywords

  • Gingival index
  • Oral Hygiene Index-Simplified (OHI-S)
  • Self-Efficacy
  • Self-Esteem
  • Orphanages
  • Dental Health Education
03

In context

Dental Plaque

352 studies on the registry are indexed under Dental Plaque; 60 are open to participants now.

This study's enrollment of 264 is above the median of 56 across 316 interventional studies indexed under Dental Plaque.

Browse Dental Plaque studies →

Lead sponsor

Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
264 participants (actual)

Study arms

  • Active comparator
    Conventional dental health education group

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

    Behavioral: Conventional dental health education

  • Experimental
    Game based dental health education group

    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

  • Experimental
    Peer-group based dental health education group

    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

  • BehavioralConventional dental health education

    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

  • BehavioralGame based dental health education

    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.

  • BehavioralPeer-group based dental health education

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, 1 month, 3 months, and 6 months

  2. 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.

    Time frame: Baseline, 1 month, 3 months, and 6 months

Secondary outcomes

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

    Evaluated using an interviewer-administered, adapted 3-point Likert scale (1 = Disagree, 2 = Neutral, 3 = Agree) designed for pediatric populations. Individual item scores are summed to yield a total continuous score. Higher scores reflect greater oral health care self-efficacy.

    Time frame: Baseline, 3 months, and 6 months

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

    Evaluated using an interviewer-administered binary version (0,1) of the Child version of Rosenberg Self Esteem Scale tailored for children aged 7-12 years. Individual item responses are summed to yield a total continuous score ranging from 0 to 10 . Higher scores indicate higher self-esteem.

    Time frame: 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

    Evaluated using relevant self-reported items from the World Health Organization (WHO) Child Oral Health Questionnaire. Daily tooth brushing frequency (e.g., 0 = never, 1 = once a week, 2 = multiple times a week, 3 = once daily, 4 = twice or more daily) and annual dental visit frequency (ordinal categories) are recorded as distinct behavioral metrics. Higher scores reflect better self-care frequency and regular dental attendance.

    Time frame: Baseline, 1 month, 3 months, and 6 months

07

Study locations

1 site
  • Social affairs
    Alexandria, 21523, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07771634
Responsible party
nour mohamed reyad ahmed (PhD Researcher, Department of Dental Public Health, Alexandria University) — Principal investigator
First posted
Aug 18, 2026
Start date
Dec 14, 2025
Primary completion
Jul 17, 2026
Completion
Jul 27, 2026
Last update
Aug 18, 2026

Study contacts

Hala Amer, Professor
study director · Alexandria University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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