| CTRI Number |
CTRI/2024/06/069253 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of motivational interviewing and conventional oral health educational approach on oral hygiene status among 12-15 year old school children bheemuniptnam mandal -a non randomized controlled trial |
|
Scientific Title of Study
|
Effectiveness of motivational interviewing and conventional oral health educational intervention approach on oral hygiene status among 12-15 year old school children in bheemunipatnam mandal -a non randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SUMAJASREE KAMATHAM |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
| Address |
ROOM NO:5, DEPARTMENT OF PUBLIC HEALTH DENTISTRY,ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES,VISAKHAPATNAM.
ROOM NO:5, DEPARTMENT OF PUBLIC HEALTH DENTISTRY,ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES,VISAKHAPATNAM.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9182477767 |
| Fax |
|
| Email |
k.sumajasree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Vamsi krishna reddy |
| Designation |
Head of the department |
| Affiliation |
Anil neerukonda institute of dental sciences |
| Address |
Room no:5, department of public health dentistry, anil neerukonda institute of dental sciences, Visakhapatnam.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9908200033 |
| Fax |
|
| Email |
drvamsired@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumajasree kamatham |
| Designation |
Post graduate student |
| Affiliation |
Anil neerukonda institute of dental sciences |
| Address |
Room no:5, department of public health dentistry, anil neerukonda institute of dental sciences, Visakhapatnam.
Room no:5, department of public health dentistry, anil neerukonda institute of dental sciences, Visakhapatnam.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9182477767 |
| Fax |
|
| Email |
k.sumajasree@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil neerukonda institute of dental sciences |
| self |
|
|
Primary Sponsor
|
| Name |
Anil neerukonda institute of dental sciences |
| Address |
Anil neerukonda institute of dental sciences , visakhapatnam |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSumajasree kamatham |
Anil neerukonda institute of dental sciences |
Room no:5, department of public health dentistry, anil neerukonda institute of dental sciences, Visakhapatnam.
Visakhapatnam
ANDHRA PRADESH |
9182477767
k.sumajasree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee - anil neerukonda institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
educational intervention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional oral health educational intervention on oral hygiene status |
interviewing done for 15 minutes and follow up at 6 month |
| Intervention |
motivational interviewing oral health educational intervention on oral hygiene status |
interviewing done for 15 minutes and follow up at 6 month |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
children who gives assent to participate and who are present at the day of examination |
|
| ExclusionCriteria |
| Details |
individual with orthodontic treatment,
individual with systemic diseases,
individual with history of long term medication. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| oral hygiene index (ohi) scores |
0 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| plaque index(pi) scores |
0 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A non- randomized controlled clinical trial
technique will be carried out among 12-15 years aged school children in
Bheemunipatnam mandal. List of the schools will be obtained from district
educational officer. From the obtained list, the schools will be randomly
selected. Participants were selected
randomly from both the schools till the sample size is attained. Prior
permission will be obtained from the principals of selected schools. Written
informed consent will be obtained from the parents/guardians of children who
were willing to participate and fulfilled the inclusion criteria. The principal investigator will
perform the clinical examination of every participant at the baseline. Dental
examination will be done on a portable chair with participant seated in upright
position under natural light. A dental explorer and mouth mirror will be used
for oral examination. Microbial plaque
accumulation on the tooth will be measured by standard Sillness and Loe plaque
index (PI), Calculus and debris will be measured by standard oral hygiene index
simplified (OHI-S). Children in the control group will receive a conventional dental
health education session and the test group will receive a motivational
interviewing intervention. The test group protocol will include a face to face interview
with each child individually and the duration considered to be 20-25 mins which
includes watching a video on tooth eruption, dietary intake,
oral hygiene practices, regular dental visits and proper brushing techniques.
Two-way communication will be used where study participant will also get a
chance to express about their dental concerns, which will be acknowledged and
will be used to provide oral health recommendations and goals for the children.
At the end of the interview the study participants will be provided with oral health education materials.one way communication will be used to deliver conventional oral health education all together in control group participants using same audio- visual aids which will be used for test group.at the end of the session the study participants will be provided with oral health education materials.reinforcement of motivational interviewing will be given to both test group and control group during follow up visits at 3 months .at the end of the study (6monthstime interval),plaque index and oral hygiene index in both the groups will be measured by the same examiner. |