NCT07184320

Brief Summary

To assess the effectiveness of AI-based educational videos in improving patient-reported oral health outcomes.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 19, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

September 13, 2025

Last Update Submit

September 13, 2025

Conditions

Keywords

Digital Health EducationDenture CarePatient EducationInterdisciplinary CareProsthodontics

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, immediately post-intervention, 1 month, 2 months, and 3 months

Secondary Outcomes (3)

  • Change in Denture Care Knowledge Retention Score

    Baseline, immediately post-intervention, 1 month, 2 months, and 3 months

  • Patient Satisfaction with Educational Method

    Immediately post-intervention, 1 month, 2 months, and 3 months

  • Compliance with Denture Hygiene Practices

    1 month, 2 months, and 3 months post-intervention

Study Arms (2)

AI-Based Video Education

EXPERIMENTAL

Participants will receive structured AI-based video education on denture care

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

Behavioral: Conventional Oral Health Instruction

Interventions

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.

AI-Based Video Education

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

Conventional Oral Health Instruction

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 50 years old.
  • Patients are removable denture users.
  • Patients can consent.
  • Patients who completed follow-up.

You may not qualify if:

  • Patients with cognitive impairment.
  • Participants are currently rehabilitated with fixed prostheses.
  • Patients received prior structured education in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulf Medical University

Ajman, Ajman Emirate, United Arab Emirates

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2025

First Posted

September 19, 2025

Study Start

August 30, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

September 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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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