Dental PlaqueNCT07771634
Effectiveness of Dental Health Education Methods on Oral Hygiene, Oral Health Care Self-Efficacy and Self-Esteem of Young Orphans
A study testing Conventional dental health education, Game based dental health education and Peer-group based dental health education in people with Dental Plaque and Gingival Diseases, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Dental Plaque, Gingival Diseases, Oral Health
- What is being tested?
- Conventional dental health education, Game based dental health education and Peer-group based dental health education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Dec 2025to 27 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Dental Plaque, Gingival Diseases, Oral Health, Self Efficacy, Self Concept
- Being tested
- Conventional dental health education, Game based dental health education, Peer-group based dental health education
- Keywords
- Gingival index, Oral Hygiene Index-Simplified (OHI-S), Self-Efficacy, Self-Esteem, Orphanages, Dental Health Education
- Medical subject headings
- Dental Plaque, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional dental health educationBehavioural
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 educationBehavioural
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 educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional dental health education group | Active comparator | Delivered through a 30 minute session given to orphans control group. Receives: 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 Receives: 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 Receives: Behavioral: Peer-group based dental health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start14 Dec 2025
- Primary completion17 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nour mohamed reyad ahmed, Alexandria University
- Investigators
- Hala Amer, Professor, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771634
- Sponsor's protocol ID
- Orphans' Health Education
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07771634
- Acronym / sponsor ID
- Orphans' Health Education
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 14 Dec 2025 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional dental health education group | Active comparator | Behavioral: Conventional dental health educationDelivered through a 30 minute session given to orphans control group. |
| Game based dental health education group | Experimental | Behavioral: Game based dental health educationoral 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 |
| Peer-group based dental health education group | Experimental | Behavioral: Peer-group based dental health educationfrom 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 |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional dental health educationIt 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 | Behavioural | Conventional dental health education group |
| Game based dental health educationCrosswords 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. | Behavioural | Game based dental health education group |
| Peer-group based dental health educationfrom 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. | Behavioural | Peer-group based dental health education group |
Primary outcome
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
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala Amer, Professor study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional dental health education, Game based dental health education and Peer-group based dental health education in people with Dental Plaque and Gingival Diseases, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.