| CTRI Number |
CTRI/2013/04/003602 [Registered on: 30/04/2013] Trial Registered Retrospectively |
| Last Modified On: |
30/04/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of a school based oral health promotion programme to improve its effectiveness- A randomized controlled trial. |
|
Scientific Title of Study
|
Impact evaluation of a school-based oral health promotion programme – an evidence in public health practice. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana Sharda |
| Designation |
Senior lecturer |
| Affiliation |
Paciic Dental College and Hospital, |
| Address |
Department of Public Health Dentistry
Paciic Dental College and Hospital
Debari
Udaipur
Rajasthan
India
Debari
Udaipur
Rajasthan
India
Udaipur
RAJASTHAN
313024
India |
| Phone |
09828568810 |
| Fax |
02942491508 |
| Email |
shardaarchana@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Sharda |
| Designation |
Senior lecturer |
| Affiliation |
Paciic Dental College and Hospital, |
| Address |
Department of Public Health Dentistry
Paciic Dental College and Hospital
Debari
Udaipur
Rajasthan
India
Debari
Udaipur
Rajasthan
India
Udaipur
RAJASTHAN
313024
India |
| Phone |
09828568810 |
| Fax |
02942491508 |
| Email |
shardaarchana@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Sharda |
| Designation |
Senior lecturer |
| Affiliation |
Paciic Dental College and Hospital, |
| Address |
Department of Public Health Dentistry
Paciic Dental College and Hospital
Debari
Udaipur
Rajasthan
India
Debari
Udaipur
Rajasthan
India
Udaipur
RAJASTHAN
313024
India |
| Phone |
09828568810 |
| Fax |
02942491508 |
| Email |
shardaarchana@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Paciic Dental College and Hospital PAHER University
Debari
Udaipur
Rajasthan
India
Pin 313024
|
|
|
Primary Sponsor
|
| Name |
Pacific Dental College and Hospital |
| Address |
Department of Public Health Dentistry
Paciic Dental College and Hospital
Debari
Udaipur
Rajasthan
India
Pin 313024
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Paciic Dental College and Hospital |
Debari
Udaipur
Rajasthan
India
Pin 313024
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Archana Sharda |
Gurunanak Public School |
Hiren Magri
sector 4
Udaipur
Udaipur
RAJASTHAN |
02942462008
shardaarchana@yahoo.com |
| Dr Archana Sharda |
Vardhaman Public School |
Sunderwas
Udaipur
RAJASTHAN |
02942490870
shardaarchana@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Pacific Dental College and Hspital Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontal status and Dental Caries status |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group where oral health promotion intervention was not carried out |
baseline and folloup data collection after 2 years was done in the control school without any intervention and the change in the outcome variables was compared with the study group |
| Intervention |
Oral health promotion intervention |
2 years folloup study.
Study group where four sessions of oral health promotion intervention in the form of oral health education and surface treatment semianually was carried out and folloup eaxmination was done at the end of 2 years period in both study groups and analysed |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
All 12-13 years old school children in the selected schools, who gave a written informed consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
All 12-13 years old school children in the selected schools, who were not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in Oral health knowledge, attitude and behavior and Periodontalstatus and Dental caries status of the school children. |
The effect of the four semiannual oral health promotion interventions will be assessed at the end of 2 years from the baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="506"
Sample Size from India="506"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/10/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study design: A randomized controlled trial. Study population: 12- 13 years- old school children from two schools (n= 266 from intervention school and n= 240 from control school) in Udaipur, India. Study Duration: 2 years. Project intervention: The types of interventions made in this oral health promotion program: 1. Four sessions of Oral Health education at an interval of six months during the study period. 2. Four sessions of dental care services (preventive and curative) at an interval of six months. Study instrument and outcomes evaluated: A self administered structured questionnaire to assess the oral health knowledge, attitude and behavior and modified WHO oral health assessment from (1997) to assess the periodontal and dental caries status. |