- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06622863
EFFECTIVENESS OF ORAL HYGIENE INSTRUCTIONS GIVEN BY AI-GENERATED VIDEOS VS. TRADITIONAL APPROACH IN PERIODONTAL PATIENTS (OHI)
Patients attending Dubai Dental Hospital and requiring nonsurgical periodontal therapy will be invited to take part in the study. Potential participants will be screened and selected based on the inclusion and exclusion criteria
The aims of the randomized controlled trial are:
- To compare the influence of AI-generated instructions versus traditional methods in improving the oral hygiene habits of patients diagnosed with periodontitis
- To assess the time and cost effectiveness of applying AI-generated oral hygiene instructions in daily practice
- To evaluate the level of patients' engagement, preference, and satisfaction with technology-based interactions vs. patient-doctor interaction
Research design
- Prospective, in which participants will be recruited and then followed up throughout a specified period of time.
- Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups.
The study will involve two stages, 1) Digital Avatar creation and 2) Clinical component.
The participants will be randomly allocated to two equal sized groups (30 per group) using computer-generated numbers:
Control group (C): Standard oral hygiene instructions will be given verbally by the periodontics resident.
Test group (T): Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abeer Hakam
- Phone Number: 3053353797
- Email: abeer.hakam@dubaihealth.ae
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Aged 18 or over.
Diagnosed with gingivitis or generalized periodontitis, Stage I-IV and Grade A-C.
Good compliance and commitment to attend follow-up review appointments.
Willing to provide informed consent.
Exclusion Criteria:
Received periodontal treatment in the last 12 months.
Received systemic anti-inflammatory or antibiotic treatment in the last 3 months.
History of malignancy, radiotherapy, or chemotherapy.
Pregnant or lactating women.
Use of medication known to cause gingival overgrowth.
Participants that require prophylactic antibiotic.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group (C): Standard oral hygiene instructions will be given verbally by the periodontics res
|
Standard oral hygiene instructions will be given verbally by the periodontics resident
|
|
Experimental: Test group (T): Avatar-based group will receive oral hygiene instructions from a digital avatar of t
|
Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plaque and bleeding score
Time Frame: At baseline and after 3 months
|
At baseline and after 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBRU-OHI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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