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Clinical Trial Details (PDF Generation Date :- Thu, 18 May 2023 04:27:30 GMT)

CTRI Number CTRI/2021/08/035935 [Registered on: 25/08/2021] - Trial Registered Prospectively

Last Modified On 25/08/2021
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Preventive
Dentistry
Behavioral
Study Design Randomized, Parallel Group Trial
Public Title of Study Impact of dental education in 4-8 year old children undergoing treatment for dental decay
Scientific Title of Impact of motivational interviewing (MI) on caries experience in 4-8 old children undergoing
Study treatment for early childhood caries
Secondary IDs if Any Secondary ID Identifier
NIL NIL
Details of Principal Details of Principal Investigator
Investigator or overall
Name Bokka Neelima
Trial Coordinator
(multi-center study) Designation Post Graduate Department of Pedodontics and Preventive Dentistry
Affiliation Vishnu Dental college
Address Room No 5 Department Of Pedodontics and Preventive Dentistry
Vishnu Dental College Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India
Phone 9676521414
Fax 08816250894
Email neelimaramana97@gmail.com
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Uloopi ks
Query)
Designation MDS Professor Department of Pedodontics and Preventive Dentistry
Affiliation Vishnu Dental college
Address Room No 5 Department Of Pedodontics and Preventive Dentistry
Vishnu Dental College Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India
Phone 9666404455
Fax 08816250894
Email uloopiks@gmail.com
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Uloopi ks
Designation MDS Professor Department of Pedodontics and Preventive Dentistry
Affiliation Vishnu Dental college
Address Room No 5 Department Of Pedodontics and Preventive Dentistry
Vishnu Dental College Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India

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Phone 9666404455
Fax 08816250894
Email uloopiks@gmail.com
Source of Monetary or Source of Monetary or Material Support
Material Support
> self funding Department of pedodontics and preventive dentistry vishnu dental college
bhimavaram 534202
Primary Sponsor Primary Sponsor Details
Name DR BOKKA NEELIMA
Address ROOM NO 5 DEPARTMENT OF PEDODONTICS AND
PREVENTIVE DENTISTRY VISHNU DENTAL COLLEGE
BHIMAVRAM 534202
Type of Sponsor Other [Post graduate student]
Details of Secondary Name Address
Sponsor
NIL NIL
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Dr Bokka Neelima Vishnu Dental College Room No 5 Department 9676521414
Of Pedodontics and 08816250894
Preventive Dentistry neelimaramana97@gm
Vishnu Dental College ail.com
Bhimavaram 534202
West Godavari
ANDHRA PRADESH
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Institutional Ethics Approved 17/02/2021 No
Committe, Vishnu
Dental College,
Bhimavram, Andhra
Pradesh-534202
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients Dental caries, unspecified
Intervention / Type Name Details
Comparator Agent
Intervention motivational interviewing A pre-tested questionnaire
which consists of 40 questions
and a diet diary will be given to
the parents at their 1st dental
visit and on 2nd visit, 30 mins
therapeutic conversation
between pediatric dentist,
parent/caregiver & children. MI
is done through audio visual
aids, brushing techniques, diet
modifications & goal setting,
Follow up at 3, 6, 9 and 12
month interval Caries
experience is assesed in both
test and control groups - using

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‘d’ component in ‘defs’ index.

Comparator Agent traditional health education A pre-tested questionnaire
which consists of 40 questions
and a diet diary will be given to
the parents at their 1st dental
visit and oral hygiene
instructions and diet counselling
will be given. Delivery mode is
educational rather than
negotiated goal setting, Follow
up at 3, 6, 9 and 12 month
interval, Caries experience is
assesed in both test and control
groups - using ‘d’ component
in ‘defs’ index
Inclusion Criteria Inclusion Criteria
Age From 4.00 Year(s)
Age To 8.00 Year(s)
Gender Both
Details Children of age 4 to 8 years <br/> Children with ECC<br/> Parents
who are willing to participate in the study<br/>
Exclusion Criteria Exclusion Criteria
Details Caries involving permanent teeth
Participation in another trial
Children with systemic illness

Method of Generating Computer generated randomization

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome Timepoints
To assess the impact of motivational interviewing 3, 6, 9, 12 months
on child’s behaviour towards oral health
practices
To assess the impact of motivational interviewing
on caries experience

Secondary Outcome Outcome Timepoints

oral hygiene status 3, 6, 9, 12 months
Target Sample Size Total Sample Size=100
Sample Size from India=100
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials
Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials
Phase of Trial N/A
Date of First 27/08/2021
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=3
Days=0
Recruitment Status of Not Applicable
Trial (Global)

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Recruitment Status of Not Yet Recruiting

Trial (India)
Publication Details NIL
Study subjects will be identified from out patient department attending Vishnu dental college and satellite clinics, Written informed consent will be obtained from parents and participating children. A pre-tested questionnaire which consists of 40 questions and a diet diary will be given to the parents at
Brief Summary their 1st dental visit. Participants divided into 2 groups.

GROUP I (MOTIVATIONAL INTERVIEWING) :

30 mins therapeutic conversation between pediatric dentist, parent/caregiver & children. MI is done through audio visual aids, brushing techniques, diet modifications & goal setting. Follow up at 3, 6, 9 and 12 month interval. Caries experience is assesed -using ‘d’ component in ‘defs’ index .The

obtained data will subjected to statistical analysis.

GROUP II (CONTROL GROUP) :

Oral hygiene instructions and diet counselling will be given. Delivery mode is educational rather than negotiated goal setting in control group. Follow up at 3, 6, 9 and 12 month interval. Caries experience is assesed -using ‘d’ component in ‘defs’ index .The obtained data will subjected to statistical

analysis.

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