NCT07183111

Brief 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 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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Nov 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Nov 2025Nov 2026

First Submitted

Initial submission to the registry

September 6, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 6, 2025

Last Update Submit

September 13, 2025

Conditions

Keywords

AI in orthodonticsChatbots and health education

Outcome Measures

Primary Outcomes (2)

  • Plaque index

    Score from O-3 0=no plaque 3=abundant plaque

    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

    T0 at baseline T1 1 month T2 2 months T 3 3 months

Secondary Outcomes (3)

  • Knowledge assessment

    T0 at baseline T1 at 1 month T2 at 2 months T3 AT 3 months

  • Patient satisfaction with instruction modality

    T0 at baseline T1 at 1 month T2 at 2 months T3 AT 3 months

  • Recall ability

    T0 at baseline T1 at 1 month T2 at 2 months T3 AT 3 months

Study Arms (2)

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

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

Other: Control group instructions given by chair side orthodontist verbally and written pamphlet as home care support

Interventions

Instructions given via artificial intelligence chatbot in form of voice instructions at chair side with Customized chatbot for remote home support

intervention group:chat bot group

Control group instructions given by chair side orthodontist verbally and written pamphlet as home care support

Control group: traditional instructions chairside verbally with pamphlet support

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Systemic conditions affecting oral hygiene
  • Cognitive impairments that may hinder comprehension
  • Patients with language barriers that might affect their understanding of

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of dentistry Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Federal, Pakistan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 38719344BACKGROUND
  • Santonocito 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.

    PMID: 40304793BACKGROUND

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Syeda Ayesha Post graduate resident

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2025

First Posted

September 19, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations