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Completed

NCT Number: NCT07771634

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

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.

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Key information

Conditions

Dental Plaque Dental Deposits Gingival Diseases Mouth Diseases Oral Health Periodontal Diseases Self Concept Self Efficacy Stomatognathic Diseases Tooth Diseases

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Social affairs

Alexandria, 21523, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Conventional dental health education

Behavioral

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

Game based dental health education

Behavioral

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.

Peer-group based dental health education

Behavioral

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.

Primary outcomes

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

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

    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

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

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

    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.

Secondary outcomes

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

    Time frame: Baseline, 3 months, and 6 months

    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.

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

    Time frame: Baseline, 3 months, and 6 months

    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.

Other outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effectiveness of Dental Health Education Methods on Oral Hygiene, Oral Health Care Self-Efficacy and Self-Esteem of Institutionalized Young Orphans: A Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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