| CTRI Number |
CTRI/2018/03/012625 [Registered on: 16/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
09/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effects of two different oral health education program, face to face and video assisted among 6 year old school children |
|
Scientific Title of Study
|
Evaluating the effectiveness of face to face and video assissted oral health education program for 6 year old school children- a randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Antara Shome |
| Designation |
Post Graduate |
| Affiliation |
The Oxford Dental College and Hospital |
| Address |
Department of Public Health Dentistry,
The Oxford Dental College and Hospital
10th Milestone, Hosur Road, Bommanahalli, Bangalore, Karnataka 560068
Bangalore
KARNATAKA
560034
India |
| Phone |
9620621625 |
| Fax |
|
| Email |
antara.shome1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudhan S |
| Designation |
Reader |
| Affiliation |
The Oxford Dental College and Hospital |
| Address |
Department of Public Health Dentistry,
The Oxford Dental College and Hospital
10th Milestone, Hosur Road, Bommanahalli, Bangalore, Karnataka 560068
Bangalore
KARNATAKA
560034
India |
| Phone |
9886298680 |
| Fax |
|
| Email |
madhusudhan6009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Antara Shome |
| Designation |
Post Graduate |
| Affiliation |
The Oxford Dental College and Hospital |
| Address |
Department of Public Health Dentistry,
The Oxford Dental College and Hospital
10th Milestone, Hosur Road, Bommanahalli, Bangalore, Karnataka 560068
Bangalore
KARNATAKA
560034
India |
| Phone |
9620621625 |
| Fax |
|
| Email |
antara.shome1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Antara Shome
Department of Public Health Dentistry, The Oxford Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Antara Shome |
| Address |
House no 152, 1st main, jakkasandra extension, Koramanagala 1st block, Bangalore |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Dr Antara Shome |
Police Public School |
KSRPcampus,Koramangala1stblock, Bangalore,Karnataka
Bangalore
KARNATAKA |
9620621625
antara.shome1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Oxford Institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
no ailment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Face to face |
In this group the knowledge and practices about oral hygiene of children through there parents were assessed before and after intervention. Here the intervention was given through conventional method like charts, models. Plaque index was also assessed before and after intervention |
| Comparator Agent |
Video assisted |
In this group the knowledge and practices about oral hygiene of children through there parents were assessed before and after intervention. Here the intervention was given through videos. Plaque index was also assessed before and after intervention |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.Children who are 6years old.
2.Children who are able to speak/read English.
3.Parents willing to give consent.
4.Children who are not suffering from any kind of physical and mental disability.
|
|
| ExclusionCriteria |
| Details |
1.Children who are suffering from any kind of physical and mental disability.
2.Children who are generally irregular in attendance.
3.Children who has undergone any kind of dental treatment.
4.Children who are not accompanied
5.Children suffering from early childhood caries |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The difference in plaque levels will be assessed using Turesky-Gilmore-Glickman modification of Quigley Hein Plaque Index.
2.The difference in oral hygiene knowledge and practice will be assessed using questionnaire.
|
1.All parameters will be assessed at baseline an after 30 days.
2.oral health education will be given at 1st day and 15th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcomes |
0 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2017 |
| Date of Study Completion (India) |
05/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="4" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was a randomized control trial evaluating the effectiveness of face to face and video assisted oral health education program for 6 year old school children of Police public School where the first intervention was given after assessing their oral hygiene by Turskey Gilmore Glickman modification of the Quigley Hein Paque Index for both the groups and the knowledge and practices by questionnaire given to their parents. Group A received face to face education where as group B received video -assisted education after the evaluation of their plaque index. Recall appointments were carried out at 15th and 30th day. At 15th day reinforcement of oral health education was done and at 30th day Plaque, knowledge and practices were reassessed.
|