Complete EdentulismNCT07184320
AI-authored Video for Denture Care: an RCT
A study testing AI-Based Video Education on Denture Care and Conventional Oral Health Instruction in people with Complete Edentulism and Partial Denture, run by Sherif Aly Sadek at 1 site in United Arab Emirates.
Trial summary
To assess the effectiveness of AI-based educational videos in improving patient-reported oral health outcomes. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Complete Edentulism, Partial Denture, Partial Edentulism in the Maxilla or in the Mandible
- What is being tested?
- AI-Based Video Education on Denture Care and Conventional Oral Health Instruction
- 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
- 50 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 20 Sep 2025to 20 Apr 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 50 years old.
- Patients who are receiving removable dentures.
- Patients can consent.
- Patients who completed follow-up.
Who cannot join
- Patients with cognitive impairment.
- Participants are currently rehabilitated with fixed prostheses.
- Patients received prior structured education in the last 6 months.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Gulf Medical University
Ajman, Ajman Emirate
About this study
Official title: Impact of a Generative-AI Authored Educational Video Versus Verbal Instruction on Denture Care and Oral Health-related Quality of Life in Older Adults: a Randomized Controlled Trial
To assess the effectiveness of AI-based educational videos in improving patient-reported oral health outcomes.
Read the detailed description
This study adopts a two-arm, parallel-group randomized controlled trial (RCT) design to compare the effectiveness of AI-based video education versus conventional oral health instruction in improving denture care knowledge, patient satisfaction, and oral health-related quality of life among older adults receiving removable prostheses.
- Conditions
- Complete Edentulism, Partial Denture, Partial Edentulism in the Maxilla or in the Mandible
- Being tested
- AI-Based Video Education on Denture Care, Conventional Oral Health Instruction
- Keywords
- Digital Health Education, Denture Care, Patient Education, Interdisciplinary Care, Prosthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Based Video Education on Denture CareBehavioural
The intervention consists of an AI-based educational video module, approximately 8 minutes in duration, designed to improve denture care practices. It uses step-by-step, visually engaging demonstrations with AI-guided narration to enhance understanding, recall, and adherence.
Conventional Oral Health InstructionBehavioural
Participants in the control group will receive conventional oral health education delivered verbally and chairside by the prosthodontic team. The standardized instruction includes information on denture hygiene techniques, appropriate storage of dentures overnight, mucosal care
| Study group | Role | What they receive |
|---|---|---|
| AI-Based Video Education | Experimental | Participants will receive structured AI-based video education on denture care Receives: Behavioral: AI-Based Video Education on Denture Care |
| Conventional Oral Health Instruction | Active comparator | Participants will receive conventional chairside verbal oral health instruction from the prosthodontic team on denture care Receives: Behavioral: Conventional Oral Health Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Health-Related Quality of Life (OHIP-14 Score)
The primary outcome is the mean change in OHIP-14 total score from baseline to follow-up assessments.
Measured: Baseline, 1 month, 2 months, and 3 months
Secondary outcomes (3)
Change in Denture Care Knowledge Retention Score
Measured using a structured denture care knowledge quiz assessing correct cleaning frequency, storage methods, avoidance of harmful practices, recognition of poor fit, and oral hygiene procedures.
Measured: Baseline, 1 month, 2 months, and 3 months
Patient Satisfaction with Educational Method
Measured using a 5-point Likert scale questionnaire evaluating clarity, usefulness, acceptability, and confidence in applying denture care practices after receiving the assigned intervention (AI-based video or conventional oral instruction).
Measured: Baseline, 1 month, 2 months, and 3 months
Compliance with Denture Hygiene Practices
Assessed with a structured self-reported checklist of daily denture care practices, including cleaning frequency, storage behaviour, and oral mucosal care.
Measured: Baseline, 1 month, 2 months, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start20 Sep 2025
- Primary completion20 Feb 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherif Aly Sadek
- Sponsor type
- University, hospital or other
- Collaborators
- Gulf Medical University
- Responsible party
- Sponsor-investigator, Sherif Aly Sadek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184320
- Sponsor's protocol ID
- IRB-COD-FAC-06-Aug-2025
- Status last verified
- Jun 2026
- First submitted
- 13 Sep 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified, aggregate outcome data (summary of OHIP-14 scores, knowledge quiz results, and satisfaction ratings) will be shared. Individual-level raw data will not be shared. Data will be made available in summary tables upon reasonable request for academic purposes, subject to approval by the principal investigator and the Institutional Review Board.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Generative-AI Authored Educational Video Versus Verbal Instruction on Denture Care and Oral Health-related Quality of Life in Older Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07184320
- Acronym / sponsor ID
- IRB-COD-FAC-06-Aug-2025
- Conditions
- Complete Edentulism, Partial Denture, Partial Edentulism in the Maxilla or in the Mandible
- Keywords
- Digital Health Education, Denture Care, Patient Education, Interdisciplinary Care, Prosthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sherif Aly SadekUniversity, hospital or other
- Collaborators
- Gulf Medical University
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 19 Sep 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.
To assess the effectiveness of AI-based educational videos in improving patient-reported oral health outcomes.
Detailed description
This study adopts a two-arm, parallel-group randomized controlled trial (RCT) design to compare the effectiveness of AI-based video education versus conventional oral health instruction in improving denture care knowledge, patient satisfaction, and oral health-related quality of life among older adults receiving removable prostheses.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Based Video Education | Experimental | Behavioral: AI-Based Video Education on Denture CareParticipants will receive structured AI-based video education on denture care |
| Conventional Oral Health Instruction | Active comparator | Behavioral: Conventional Oral Health InstructionParticipants will receive conventional chairside verbal oral health instruction from the prosthodontic team on denture care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 50 years old.
- Patients who are receiving removable dentures.
- Patients can consent.
- Patients who completed follow-up.
Key exclusion criteria (3 listed)
- Patients with cognitive impairment.
- Participants are currently rehabilitated with fixed prostheses.
- Patients received prior structured education in the last 6 months.
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 |
|---|---|---|
| AI-Based Video Education on Denture CareThe intervention consists of an AI-based educational video module, approximately 8 minutes in duration, designed to improve denture care practices. It uses step-by-step, visually engaging demonstrations with AI-guided narration to enhance understanding, recall, and adherence. | Behavioural | AI-Based Video Education |
| Conventional Oral Health InstructionParticipants in the control group will receive conventional oral health education delivered verbally and chairside by the prosthodontic team. The standardized instruction includes information on denture hygiene techniques, appropriate storage of dentures overnight, mucosal care | Behavioural | Conventional Oral Health Instruction |
Primary outcome
Change in Oral Health-Related Quality of Life (OHIP-14 Score)
Time frame: Baseline, 1 month, 2 months, and 3 months
The primary outcome is the mean change in OHIP-14 total score from baseline to follow-up assessments.
3 secondary outcomes
Change in Denture Care Knowledge Retention Score
Time frame: Baseline, 1 month, 2 months, and 3 months
Patient Satisfaction with Educational Method
Time frame: Baseline, 1 month, 2 months, and 3 months
Compliance with Denture Hygiene Practices
Time frame: Baseline, 1 month, 2 months, and 3 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 29 Jun 2026.
- Individual participant dataSharing planned: Yes. Only de-identified, aggregate outcome data (summary of OHIP-14 scores, knowledge quiz results, and satisfaction ratings) will be shared. Individual-level raw data will not be shared. Data will be made available in summary tables upon reasonable request for academic purposes, subject to approval by the principal investigator and the Institutional Review Board.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Based Video Education on Denture Care and Conventional Oral Health Instruction in people with Complete Edentulism and Partial Denture, run by Sherif Aly Sadek at 1 site in United Arab Emirates.
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 4 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 29 Jun 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 United Arab Emirates. 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 Health-Related Quality of Life (OHIP-14 Score) (time frame: Baseline, 1 month, 2 months, and 3 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 29 Jun 2026.