Focus of the Study is Plaque and Gingival Index Score Before and After InstructionsNCT07183111
Comparison of Traditional Instructions Vs AI Based Instructions With Customized Chat GPT as Remote Support System on Education of Orthodontic Patients
A study testing Instructions given via artificial intelligence chatbot in form of voice instructions at chair side with Customized chatbot for remote home support in people with Focus of the Study is Plaque and Gingival Index Score Before and After Instructions and Satisfaction Assessment of Orthodontic Patients With Both Instruction Modalities, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
This study will assess the impact of voice instructions delivered by advance voice feature of Chat gpt followed by remote support with chatbot in form of customized chat gpt named Brace AI which is customized by principal investigator.AI generate post operative instructions will be compared with post bracketing… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study is Plaque and Gingival Index Score Before and After Instructions, Satisfaction Assessment of Orthodontic Patients With Both Instruction Modalities, Knowledge Assessment
- What is being tested?
- Instructions given via artificial intelligence chatbot in form of voice instructions at chair side with Customized chatbot for remote home support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2025to Nov 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-30 years undergoing bracket placement
- No prior experience of orthodontic treatment
- In good state of physical and mental health
- Understand the medium of instructions properly which will be Urdu language in this study
- Internally motivated patients with fairly good oral hygiene at the start of treatment
- Access to smart phone or internet at home
Who cannot join
- Systemic conditions affecting oral hygiene
- Cognitive impairments that may hinder comprehension
- Patients with language barriers that might affect their understanding of
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
School of dentistry Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad, Federal
Post graduate resident, +923315578208, syedaaysha97@gmail.com
Syeda Ayesha Fatima
About this study
Official title: Comparison of Traditional Instructions Vs AI Based Instructions With Customized Chat GPT as Remote Support System on Education of Orthodontic Patients:A Randomised Control Trial
This study will assess the impact of voice instructions delivered by advance voice feature of Chat gpt followed by remote support with chatbot in form of customized chat gpt named Brace AI which is customized by principal investigator.AI generate post operative instructions will be compared with post bracketing instructions given verbally in traditional chair side manner and home support with pamphlet in terms of oral hygiene outcome ,satisfaction with both modalities of instruction , recall ability and knowledge of the orthodontic patients
- Conditions
- Focus of the Study is Plaque and Gingival Index Score Before and After Instructions, Satisfaction Assessment of Orthodontic Patients With Both Instruction Modalities, Knowledge Assessment, Recall Ability of Orthodontic Instructions With Both Modalities
- Being tested
- Instructions given via artificial intelligence chatbot in form of voice instructions at chair side with Customized chatbot for remote home support, Control group instructions given by chair side orthodontist verbally and written pamphlet as home care support
- Keywords
- AI in orthodontics, Chatbots and health education
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructions given via artificial intelligence chatbot in form of voice instructions at chair side with Customized chatbot for remote home supportOther
Instructions given via artificial intelligence chatbot in form of voice instructions at chair side with Customized chatbot for remote home support
Control group instructions given by chair side orthodontist verbally and written pamphlet as home care supportOther
Control group instructions given by chair side orthodontist verbally and written pamphlet as home care support
| Study group | Role | What they receive |
|---|---|---|
| intervention group:chat bot group | Experimental | Intervention group : receives instructions from advance voice feature of chat gpt chair side and customized chat gpt as home care remote support in form of chat bot Receives: Other: Instructions given via artificial intelligence chatbot in form of voice instructions at chair side with Customized chatbot for remote home support |
| Control group: traditional instructions chairside verbally with pamphlet support | Active comparator | Control group : receives instructions verbally on chair side with pamphlet as home care remote support Receives: Other: Control group instructions given by chair side orthodontist verbally and written pamphlet as home care support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
Score from O-3 0=no plaque 3=abundant plaque
Measured: T0 at baseline T1 1 month T2 2 months T 3 3 months
Modified gingival index
Score from 0-4 0= normal gingival tissue 4=erythema edema gingival hypertrophy and spontaneous bleeding
Measured: T0 at baseline T1 1 month T2 2 months T 3 3 months
Secondary outcomes (3)
Knowledge assessment
Scale from 0-4 0=very little 4=excellent
Measured: T0 at baseline T1 at 1 month T2 at 2 months T3 AT 3 months
Patient satisfaction with instruction modality
Measured with satisfaction scale 0-4 0=very unsatisfactory 4=very satisfactory
Measured: T0 at baseline T1 at 1 month T2 at 2 months T3 AT 3 months
Recall ability
Measured via quiz
Measured: T0 at baseline T1 at 1 month T2 at 2 months T3 AT 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 startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Focus of the Study is Plaque and Gingival Index Score Before and After InstructionsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Syeda Ayesha Fatima, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183111
- Sponsor's protocol ID
- SOD/ERB/2025/90
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sevgi M, Antaki F, Keane PA. Medical education with large language models in ophthalmology: custom instructions and enhanced retrieval capabilities. Br J Ophthalmol. 2024 Sep 20;108(10):1354-1361. doi: 10.1136/bjo-2023-325046.
PubMed 38719344Santonocito S, Cicciu M, Ronsivalle V. Evaluation of the impact of AI-based chatbot on orthodontic patient education: a preliminary randomised controlled trial. Clin Oral Investig. 2025 Apr 30;29(5):278. doi: 10.1007/s00784-025-06356-8.
PubMed 40304793
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Traditional Instructions Vs AI Based Instructions With Customized Chat GPT as Remote Support System on Education of Orthodontic Patients:A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07183111
- Acronym / sponsor ID
- SOD/ERB/2025/90
- Conditions
- Focus of the Study is Plaque and Gingival Index Score Before and After Instructions, Satisfaction Assessment of Orthodontic Patients With Both Instruction Modalities, Knowledge Assessment, Recall Ability of Orthodontic Instructions With Both Modalities
- Keywords
- AI in orthodontics, Chatbots and health education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- 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.
This study will assess the impact of voice instructions delivered by advance voice feature of Chat gpt followed by remote support with chatbot in form of customized chat gpt named Brace AI which is customized by principal investigator.AI generate post operative instructions will be compared with post bracketing instructions given verbally in traditional chair side manner and home support with pamphlet in terms of oral hygiene outcome ,satisfaction with both modalities of instruction , recall ability and knowledge of the orthodontic patients
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group:chat bot group | Experimental | Other: Instructions given via artificial intelligence chatbot in form of voice instructions at chair side with Customized chatbot for remote home supportIntervention group : receives instructions from advance voice feature of chat gpt chair side and customized chat gpt as home care remote support in form of chat bot |
| Control group: traditional instructions chairside verbally with pamphlet support | Active comparator | Other: Control group instructions given by chair side orthodontist verbally and written pamphlet as home care supportControl group : receives instructions verbally on chair side with pamphlet as home care remote support |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18-30 years undergoing bracket placement
- No prior experience of orthodontic treatment
- In good state of physical and mental health
- Understand the medium of instructions properly which will be Urdu language in this study
- Internally motivated patients with fairly good oral hygiene at the start of treatment
Key exclusion criteria (3 listed)
- Systemic conditions affecting oral hygiene
- Cognitive impairments that may hinder comprehension
- Patients with language barriers that might affect their understanding of
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 |
|---|---|---|
| Instructions given via artificial intelligence chatbot in form of voice instructions at chair side with Customized chatbot for remote home supportInstructions given via artificial intelligence chatbot in form of voice instructions at chair side with Customized chatbot for remote home support | Other | intervention group:chat bot group |
| Control group instructions given by chair side orthodontist verbally and written pamphlet as home care supportControl group instructions given by chair side orthodontist verbally and written pamphlet as home care support | Other | Control group: traditional instructions chairside verbally with pamphlet support |
Primary outcome
Plaque index
Time frame: T0 at baseline T1 1 month T2 2 months T 3 3 months
Score from O-3 0=no plaque 3=abundant plaque
Modified gingival index
Time frame: T0 at baseline T1 1 month T2 2 months T 3 3 months
Score from 0-4 0= normal gingival tissue 4=erythema edema gingival hypertrophy and spontaneous bleeding
3 secondary outcomes
Knowledge assessment
Time frame: T0 at baseline T1 at 1 month T2 at 2 months T3 AT 3 months
Patient satisfaction with instruction modality
Time frame: T0 at baseline T1 at 1 month T2 at 2 months T3 AT 3 months
Recall ability
Time frame: T0 at baseline T1 at 1 month T2 at 2 months T3 AT 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 19 Sep 2025.
- Background: PubMed 38719344Sevgi M, Antaki F, Keane PA. Medical education with large language models in ophthalmology: custom instructions and enhanced retrieval capabilities. Br J Ophthalmol. 2024 Sep 20;108(10):1354-1361. doi: 10.1136/bjo-2023-325046.
- Background: PubMed 40304793Santonocito S, Cicciu M, Ronsivalle V. Evaluation of the impact of AI-based chatbot on orthodontic patient education: a preliminary randomised controlled trial. Clin Oral Investig. 2025 Apr 30;29(5):278. doi: 10.1007/s00784-025-06356-8.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructions given via artificial intelligence chatbot in form of voice instructions at chair side with Customized chatbot for remote home support in people with Focus of the Study is Plaque and Gingival Index Score Before and After Instructions and Satisfaction Assessment of Orthodontic Patients With Both Instruction Modalities, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 6 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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 Pakistan. 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?
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 Syeda Ayesha Post graduate resident (+923315578208, syedaaysha97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (time frame: T0 at baseline T1 1 month T2 2 months T 3 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183111, which also lists 2 linked publications.
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 19 Sep 2025.