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
Phase: NA
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
Sponsor: Pakistan Institute of Medical Sciences

RESEARCH TITLED :
Comparison of Traditional Instructions Vs AI based Instructions with
Customized ChatGPT as Remote Support System on Education of Orthodontic
Patients: A Randomized Control Trial
Date of ERB approval: 31/7/25

MATERIALS AND METHODS:
Study Design: A two arm randomized controlled trial (RCT) will be conducted
SETTING: Department of Orthodontics, School of Dentistry Islamabad
Participants
DURATION OF STUDY: One year after the approval of synopsis
SAMPLE SIZE: By using open EPI calculator sample size is 60 (30 each group) wit
level of significance 5%,power of test 80%.Mean of 1.03 and 1.27 with standard
deviation of 0.06 and 0.08 in intervention group and control group respectively.(3)
SAMPLE SELECTION:
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Inclusion Criteria:
o Patients aged 18–30 years undergoing bracket placement
o No prior experience of orthodontic treatment
o In good state of physical and mental health
o Understand the medium of instructions properly which will be
Urdu language in this study
o Internally motivated patients with fairly good oral hygiene at
the start of treatment
o Access to smart phone or internet at home
Exclusion Criteria;
o Systemic conditions affecting oral hygiene
o Cognitive impairments that may hinder comprehension
o Patients with language barriers that might affect their
understanding of instructions
SAMPLING TECHNIQUE: Simple random probability sampling will be employed
DATA COLLECTION PROCEDURE
Interventions:

o Group A(Intervention Group): Verbal instruction will be given
by Advance Voice Feature of ChatGPT plus in chair side
sitting.Moreover an AI assistant Brace AI ,a custom GPT tailored by
researcher will be shared with patients via QR code or URL link which
will be available to patients for remote support
o Group B(Control Group): Verbal instructions will be given to
patients after placement of brackets in a traditional chair-side manner
by an experienced orthodontist.All the instructions and information
given will be in accordance with the guidelines given by leading
orthodontic societies (American Board of Orthodontics).Moreover a
written pamphlet including all post braces care will be given to
patients
Outcome Measurement:
o Oral hygiene outcome will be measured by using oral hygiene
indices (Silness Loe plaque index(9), Modified gingival index(10)
measured at T0,T1,T2,T3
o Patient satisfaction,engagement and interactivity will be
assessed using a questionnaire(Annexure 2) filled at(T0), 1
month(T1),(T2 )and (T3)
o Ability to recall will be assessed by taking a recall quiz at
T0,T1,T2,T3
STATISTICAL ANALYSIS:
Data analysis will be done using SPSS 23 software.qualitative variables i.e
gender will be presented as frequency and percentages. Quantitative variables i.e
age will be measured as mean and standard deviation. For intra- and intergroup
comparisons of parametric data, the paired sample t-test and independent t-test will
be applied, respectively. In cases of non-parametric data, the Mann–Whitney U test
will be used for intergroup comparisons.. Reliability of questionnaire will be checked
by cronbach’s alpha. The level of significance will be set at an alpha level of < 0.05,
and 95% confidence intervals.
CONSENT FORM
Comparison of Traditional Instructions Vs AI based Instructions with
Customized ChatGPT as Remote Support System on Education of Orthodontic
Patients: A Randomized Control Trial

RESEARCH CONDUCTOR:
1.
I confirm that I have understood the research information for the
above study and have had the opportunity to ask questions
2.
I understand that my participation is voluntary and that I am free to
withdraw at any time, without giving any reason and without any medical care or
legal rights being affected
3.
I understand that the above research conductor from the Department
of Orthodontics, School of Dentistry, Islamabad will have access to my personal
details
4.
I understand that any data or information used in any publication,
which arise from this study will be anonymous
5.
I understand that all data will be secured and is covered by Data
Protection act
6.
I agree that the conductor can contact me on the telephone number
mentioned below to arrange an interview at time and location to suit me
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