GingivitisOHINCT06622863
EFFECTIVENESS OF ORAL HYGIENE INSTRUCTIONS GIVEN BY AI-GENERATED VIDEOS VS. TRADITIONAL APPROACH IN PERIODONTAL PATIENTS
A study testing Standard oral hygiene instructions will be given verbally by the periodontics resident and Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice in people with Gingivitis and Periodontitis, run by Mohammed Bin Rashid University of Medicine and Health Sciences.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontitis
- What is being tested?
- Standard oral hygiene instructions will be given verbally by the periodontics resident and Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice
- 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
- 60 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2024to 30 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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
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:
Read more
- 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.
- Conditions
- Gingivitis, Periodontitis
- Being tested
- Standard oral hygiene instructions will be given verbally by the periodontics resident, Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard oral hygiene instructions will be given verbally by the periodontics residentBehavioural
Standard oral hygiene instructions will be given verbally by the periodontics resident
Avatar-based group will receive oral hygiene instructions from a digital avatar of their choiceBehavioural
Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice
| Study group | Role | What they receive |
|---|---|---|
| Control group (C): Standard oral hygiene instructions will be given verbally by the periodontics res | Active comparator | Not described Receives: Behavioral: 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 t | Experimental | Not described Receives: Behavioral: Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque and bleeding score
Measured: At baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start6 Oct 2024 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Hakam, Mohammed Bin Rashid University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622863
- Sponsor's protocol ID
- MBRU-OHI
- Acronym
- OHI
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF ORAL HYGIENE INSTRUCTIONS GIVEN BY AI-GENERATED VIDEOS VS. TRADITIONAL APPROACH IN PERIODONTAL PATIENTS
- ClinicalTrials.gov ID
- NCT06622863
- Acronym / sponsor ID
- OHI / MBRU-OHI
- Conditions
- Gingivitis, Periodontitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health SciencesUniversity, hospital or other
- Study start
- 6 Oct 2024 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Oct 2024 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (C): Standard oral hygiene instructions will be given verbally by the periodontics res | Active comparator | Behavioral: 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 t | Experimental | Behavioral: Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Standard oral hygiene instructions will be given verbally by the periodontics residentStandard oral hygiene instructions will be given verbally by the periodontics resident | Behavioural | Control group (C): Standard oral hygiene instructions will be given verbally by the periodontics res |
| Avatar-based group will receive oral hygiene instructions from a digital avatar of their choiceAvatar-based group will receive oral hygiene instructions from a digital avatar of their choice | Behavioural | Test group (T): Avatar-based group will receive oral hygiene instructions from a digital avatar of t |
Primary outcome
Plaque and bleeding score
Time frame: At baseline and after 3 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 2 Oct 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Standard oral hygiene instructions will be given verbally by the periodontics resident and Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice in people with Gingivitis and Periodontitis, run by Mohammed Bin Rashid University of Medicine and Health Sciences.
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 6 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 2 Oct 2024. 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 Abeer Hakam (3053353797, abeer.hakam@dubaihealth.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque and bleeding score (time frame: At baseline and after 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 2 Oct 2024.