Oral Health Self-efficacyNCT07083414
Impact of Digital Oral Health Educational Program on a Group of Geriatrics Oral Health and Quality of Life Compared to Standard Oral Health Educational Program in Egypt
A study testing elderly participant will receive digital educational oral health program. and elderly participant will receive the standard oral health education in geriatric institution. in people with Oral Health Self-efficacy and Healthy Participants Study, run by Cairo University.
Trial summary
The aim of the study is to evaluate the impact of a digital oral health education program on the oral health status and quality of life for geriatric populations compared to standard oral health education in Egypt. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Health Self-efficacy, Healthy Participants Study
- What is being tested?
- elderly participant will receive digital educational oral health program. and elderly participant will receive the standard oral health education in geriatric institution.
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Old age population above years old.
- Participants who is willing to confirm consent for the educational program and assessment.
- Participants without disability that interfere during communication.
Who cannot join
- Individuals with palliative care and rehabilitation ward, presence of mental disorder, had dangerous communicable disease.
- Participants who refused to participate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Digital Oral Health Educational Program on a Group of Geriatrics Oral Health and Quality of Life Compared to Standard Oral Health Educational Program in Egypt: a Cluster Randomized Control Trial
The aim of the study is to evaluate the impact of a digital oral health education program on the oral health status and quality of life for geriatric populations compared to standard oral health education in Egypt.
Read the detailed description
The principal investigator will carry out all educational programs.
For both interventions:
- Informed consent from elderly participating.
- Baseline records plaque index(Appendix : silness and loe), WHO questionnaire (Appendix : oral health survey) and GOHAI (Appendix : Geriatric Oral Health Assessment Index).
- Allocation (The outcome will be immediately recorded and sealed in a numbered, opaque envelope corresponding to the cluster. These envelopes will only be opened after the cluster has been enrolled in the study, thus preventing any fore knowledge of the allocation and reducing the risk of selection bias).
- Examination will be performed to assess the inclusion criteria.
All geriatric institution will then be allocated into either one of the groups alternatively depending on the educational program used as follows:
Group I (Experimental group); elderly participant will receive digital educational oral health program.
Group II (Control group); elderly participant will receive the standard oral health education in geriatric institution.
. Group I (Experimental group); elderly participant will receive digital educational oral health program.
The digital oral health educational program will be through 6 months and follow up 3 times every 1.5 months through this period. The content will focus on age-related oral health changes, oral hygiene practices, denture care, and disease prevention.
Digital 3D model video designed for the elderly population. Posters Flyers Power-point Cast model Educational videos
. Group II (Control group); elderly participant will receive the standard oral health education in geriatric institution. Participants in the control group will receive standard oral health information. No education sessions will be conducted during the 6 months till the final assessment. However, after the final assessment at 6 months, the control group will be offered access to the digital educational program.
- Being tested
- elderly participant will receive digital educational oral health program., elderly participant will receive the standard oral health education in geriatric institution.
- Keywords
- Educational program, Oral health program, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elderly participant will receive digital educational oral health program.Device
Also called Digital oral health educational program
- Digital 3D Model Video: A custom-designed 3D animated video illustrating proper tooth brushing techniques tailored for elderly individuals, as well as comprehensive guidance on denture care.
- Written Educational Materials: Printed resources including posters and flyers that provide key messages and visual demonstrations related to maintaining good oral hygiene practices.
- PowerPoint Presentations and Educational Videos: Visual and audiovisual materials focusing on the importance of balanced nutrition in maintaining oral and general health, and early detection of oral cancer, including risk factors, signs, and recommended screening practices.
- Hands-on Brushing Technique Training: Practical sessions utilizing dental cast models to demonstrate and allow participants to practice effective brushing techniques under supervision.
elderly participant will receive the standard oral health education in geriatric institution.Other
Also called Standard oral health educational program
The use of traditional health promotion materials, such as leaflets and posters, remains valuable in community settings. These tools are cost-effective, easy to produce, and continue to serve as effective educational resources for adults, including the elderly. Participants in the control group will receive standard oral health information. No education sessions will be conducted during the 6 months till the final assessment. However, after the final assessment at 6 months, the control group will be offered access to the digital educational program.
| Study group | Role | What they receive |
|---|---|---|
| elderly participant will receive digital educational oral health program. | Experimental | The digital oral health educational program will be through 6 months and follow up 3 times every 1.5 months through this period. The content will focus on age-related oral health changes, oral hygiene practices, denture care, and disease prevention. Receives: Device: elderly participant will receive digital educational oral health program. |
| elderly participant will receive the standard oral health education in geriatric institution. | Active comparator | Participants in the control group will receive standard oral health information. No education sessions will be conducted during the 6 months till the final assessment. However, after the final assessment at 6 months, the control group will be offered access to the digital educational program. Receives: Other: elderly participant will receive the standard oral health education in geriatric institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental plaque
It measures the thickness of dental plaque at the gingival area by using dental mirror and pen light then score ranging from to per tooth surface.
0= absence of microbial plaque
- thin film of microbial plaque along the free gingival margin
- moderate accumulation with plaque in sulcus
- large amount of plaque in sulcus or pocket along with free gingival margin
Measured: Assessed at baseline and after 6 months
Secondary outcomes (1)
General oral health status (WHO oral health assessment form for adult, 2013)
Use form to evaluate oral hygiene practices, dental needs, and clinical oral conditions. This tool assesses multiple oral health domains, including the condition of the dentition (such as decayed, filled, or missing teeth), periodontal status using the modified Community Periodontal Index (CPI), loss of attachment, dental erosion, dental trauma, enamel fluorosis, oral mucosal lesions, denture presence, and treatment urgency. For periodontal status (CPI), scores range from 0 to 4, where 0 indicates a healthy condition, and higher scores reflect increasing severity, such as bleeding, calculus presence, and periodontal pocket depth (up to 6 or more). Similarly, loss of attachment is scored from 0 to 4, with higher values indicating greater tissue destruction (ranging from 0-3 up to 12 mm). Other conditions such as erosion, trauma, and mucosal lesions are recorded based on presence or severity. Higher scores in the periodontal and attachment domains indicate worse oral health conditions.
Measured: Assessed at baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Dec 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health Self-efficacyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weam abdelhamid hassab elnaby elshoura, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083414
- Sponsor's protocol ID
- Edu. Program
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Digital Oral Health Educational Program on a Group of Geriatrics Oral Health and Quality of Life Compared to Standard Oral Health Educational Program in Egypt: a Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07083414
- Acronym / sponsor ID
- Edu. Program
- Keywords
- Educational program, Oral health program, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 24 Jul 2025 (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.
The aim of the study is to evaluate the impact of a digital oral health education program on the oral health status and quality of life for geriatric populations compared to standard oral health education in Egypt.
Detailed description
The principal investigator will carry out all educational programs.
For both interventions:
- Informed consent from elderly participating.
- Baseline records plaque index(Appendix : silness and loe), WHO questionnaire (Appendix : oral health survey) and GOHAI (Appendix : Geriatric Oral Health Assessment Index).
- Allocation (The outcome will be immediately recorded and sealed in a numbered, opaque envelope corresponding to the cluster. These envelopes will only be opened after the cluster has been enrolled in the study, thus preventing any fore knowledge of the allocation and reducing the risk of selection bias).
- Examination will be performed to assess the inclusion criteria.
All geriatric institution will then be allocated into either one of the groups alternatively depending on the educational program used as follows:
Group I (Experimental group); elderly participant will receive digital educational oral health program.
Group II (Control group); elderly participant will receive the standard oral health education in geriatric institution.
. Group I (Experimental group); elderly participant will receive digital educational oral health program.
The digital oral health educational program will be through 6 months and follow up 3 times every 1.5 months through this period. The content will focus on age-related oral health changes, oral hygiene practices, denture care, and disease prevention.
Digital 3D model video designed for the elderly population. Posters Flyers Power-point Cast model Educational videos
. Group II (Control group); elderly participant will receive the standard oral health education in geriatric institution. Participants in the control group will receive standard oral health information. No education sessions will be conducted during the 6 months till the final assessment. However, after the final assessment at 6 months, the control group will be offered access to the digital educational program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elderly participant will receive digital educational oral health program. | Experimental | Device: elderly participant will receive digital educational oral health program.The digital oral health educational program will be through 6 months and follow up 3 times every 1.5 months through this period. The content will focus on age-related oral health changes, oral hygiene practices, denture care, and disease prevention. |
| elderly participant will receive the standard oral health education in geriatric institution. | Active comparator | Other: elderly participant will receive the standard oral health education in geriatric institution.Participants in the control group will receive standard oral health information. No education sessions will be conducted during the 6 months till the final assessment. However, after the final assessment at 6 months, the control group will be offered access to the digital educational program. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Old age population above years old.
- Participants who is willing to confirm consent for the educational program and assessment.
- Participants without disability that interfere during communication.
Key exclusion criteria (2 listed)
- Individuals with palliative care and rehabilitation ward, presence of mental disorder, had dangerous communicable disease.
- Participants who refused to participate.
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 |
|---|---|---|
| elderly participant will receive digital educational oral health program.Also: Digital oral health educational program* Digital 3D Model Video: A custom-designed 3D animated video illustrating proper tooth brushing techniques tailored for elderly individuals, as well as comprehensive guidance on denture care. * Written Educational Materials: Printed resources including posters and flyers that provide key messages and visual demonstrations related to maintaining good oral hygiene practices. * PowerPoint Presentations and Educational Videos: Visual and audiovisual materials focusing on the importance of balanced nutrition in maintaining oral and general health, and early detection of oral cancer, including risk factors, signs, and recommended screening practices. * Hands-on Brushing Technique Training: Practical sessions utilizing dental cast models to demonstrate and allow participants to practice effective brushing techniques under supervision. | Device | elderly participant will receive digital educational oral health program. |
| elderly participant will receive the standard oral health education in geriatric institution.Also: Standard oral health educational programThe use of traditional health promotion materials, such as leaflets and posters, remains valuable in community settings. These tools are cost-effective, easy to produce, and continue to serve as effective educational resources for adults, including the elderly. Participants in the control group will receive standard oral health information. No education sessions will be conducted during the 6 months till the final assessment. However, after the final assessment at 6 months, the control group will be offered access to the digital educational program. | Other | elderly participant will receive the standard oral health education in geriatric institution. |
Primary outcome
Dental plaque
Time frame: Assessed at baseline and after 6 months
It measures the thickness of dental plaque at the gingival area by using dental mirror and pen light then score ranging from to per tooth surface. 0= absence of microbial plaque 1. thin film of microbial plaque along the free gingival margin 2. moderate accumulation with plaque in sulcus 3. large amount of plaque in sulcus or pocket along with free gingival margin
1 secondary outcome
General oral health status (WHO oral health assessment form for adult, 2013)
Time frame: Assessed at baseline and after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing elderly participant will receive digital educational oral health program. and elderly participant will receive the standard oral health education in geriatric institution. in people with Oral Health Self-efficacy and Healthy Participants Study, run by Cairo University.
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 2 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: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weam abdelhamid elshoura (01200003845, Weam.abdelhamid@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental plaque (time frame: Assessed at baseline and after 6 months). 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 28 Jul 2025.