| CTRI Number |
CTRI/2021/09/036979 [Registered on: 30/09/2021] Trial Registered Prospectively |
| Last Modified On: |
28/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Oral health education in children in residential homes |
|
Scientific Title of Study
|
Effectiveness of oral health education strategies among children in residential homes in Bangalore city- A quasi experimental study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angelin Mary L |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and research institute ,Bangalore |
| Address |
Government dental college and research institute, Department of public health dentistry, Fort, Bangalore.
Bangalore
KARNATAKA
560002
India |
| Phone |
7904610244 |
| Fax |
|
| Email |
angel1995mary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita Shanbhag |
| Designation |
Associate professor |
| Affiliation |
Government dental college and research institute ,Bangalore |
| Address |
Government dental college and research institute, Department of public health dentistry, Fort, Bangalore.
Bangalore
KARNATAKA
560002
India |
| Phone |
9844072744 |
| Fax |
|
| Email |
drnamita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Angelin Mary L |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and research institute ,Bangalore |
| Address |
Government dental college and research institute, Department of public health dentistry, Fort, Bangalore.
Bangalore
KARNATAKA
560002
India |
| Phone |
7904610244 |
| Fax |
|
| Email |
angel1995mary@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and research institute , Bangalore |
|
|
Primary Sponsor
|
| Name |
Angelin Mary L |
| Address |
Government dental college and research institute, Department of public health dentistry, Fort, Bangalore,560002 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Namita shanbhag |
Loving hearts charity organization |
no 123, 6th square, Central street, Austin town, 560047
Bangalore
KARNATAKA |
9844072744
drnamita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Dental College and Research Institute, Bangalore, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
11 to 14 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dentist giving oral health education |
Dentist will give oral health education through easy to comprehend power point presentations, audio
visual aids, models and posters for a duration of 6 months. |
| Intervention |
Peer leader giving oral health education |
Peer group will give oral health education through easy to comprehend power point presentations, audio
visual aids, models and posters for a duration of 6 months |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children of age 11-14 years.
|
|
| ExclusionCriteria |
| Details |
Undergone oral prophylaxis in the last 6 months.
Children suffering from acute or chronic systemic diseases.
Children suffering from behavioral disorders, psychological problems.
Physically and mentally challenged children
Children undergoing orthodontic treatment or wearing intraoral appliance
Children with restricted mouth opening, hard and soft tissue pathology making intraoral
examination difficult |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plaque index
DMFT index
Gingival index |
Baseline, 3rd month, 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oral health behaviour,
Child perception questionnaire of oral health quality of life,
Face version of modified Child Dental Anxiety Scale |
Baseline, 3rd month, 6th month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/10/2021 |
| Date of Study Completion (India) |
06/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Oral health education at the right age can help cultivate healthy oral hygiene practices in children which will benefit them for lifelong. Use of oral health education strategies is offered as a practical, cost effective and evidence-based suggestion to make the children live in a healthy environment .As there is paucity of literature in peer led oral health education strategies among children in residential homes in our state, this study will be conducted to assess the effectiveness of peer led and dentist led oral health education strategies in improving oral health among these children. Oral health education will be rendered through easy to comprehend power point presentations, audio visual aids, models and posters. In the 1st month of intervention, dentist /peer leaders will deliver information on teeth and functions, common diseases of oral cavity. In the 2nd month of intervention, dentist/peer leaders will deliver information on 5 golden principles of oral hygiene maintenance, dental plaque, identifying dental plaque by disclosing agents and tooth brushing drills. In the 3rd month of intervention, dentist/peer leaders will deliver information on dental trauma, safety in sports, tobacco, need for regular dental visits and oral care. In the 4th ,5th and 6th month dentist/peer leaders will repeat the interventions. At 3rd month and 6th month a blinded investigator will be evaluating including intra oral examination. |