| CTRI Number |
CTRI/2017/07/009151 [Registered on: 28/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
22/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effectiveness of musical toothbrush over manual toothbrush in school children |
|
Scientific Title of Study
|
Effectiveness of musical toothbrush in the assessment of Oral Health Status among 6-10 year old children in chennai- An Interventional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivedha Subburaman |
| Designation |
Post Graduate Student |
| Affiliation |
RAGAS DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no. 10, DEPARTMENT OF PUBLIC HEALTH DENTISTRY,
Ragas Dental College and Hospital
2/102,, SH 49, Uthandi, chennai, Tamil Nadu
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
9566017103 |
| Fax |
|
| Email |
nivedha4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PDMadankumar |
| Designation |
Professor and Head |
| Affiliation |
RAGAS DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of Public Health Dentistry,
Ragas Dental College and Hospital,
2/102,, SH 49, Uthandi, Tamil Nadu
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
9566017103 |
| Fax |
|
| Email |
madankumar21@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nivedha Subburaman |
| Designation |
Post Graduate Student |
| Affiliation |
RAGAS DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no. 10, DEPARTMENT OF PUBLIC HEALTH DENTISTRY,
Ragas Dental College and Hospital
2/102,, SH 49, Uthandi, chennai, Tamil Nadu
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
9566017103 |
| Fax |
|
| Email |
nivedha4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ragas Dental College and Hospital
2/102, East Coast Road, Uthandi, Chennai-600112 |
|
|
Primary Sponsor
|
| Name |
Nivedha Subburaman |
| Address |
2/102,, SH 49, Uthandi, Tamil Nadu 600119 |
| 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 |
| Dr Nivedha Subburaman |
DAV SCHOOL, ADAMBAKKAM |
Division- 1st to 5th standard,
Shree nandeeshwarar campus,
adambakkam, chennai-88
Kancheepuram
TAMIL NADU |
9566017103
nivedha4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Ragas Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oral health Status; Gingival Bleeding Index |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Manual toothbrush group |
To brush twice daily using manual toothbrush for 90 days. |
| Intervention |
Musical toothbrush Group |
Brush twice daily with musical toothbrush for 60 days by switching on the power switch. To brush for two minutes until music in the brush stops. To continue with manual toothbrush after the 60th day follow up. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Participants willing to give full consent to take part in the study |
|
| ExclusionCriteria |
| Details |
1. Participants with poor manual dexterity, differently abled children who require special assistance for brushing; 2. Participants who had visited dentist for a dental treatment past 1 month and thereafter; 3. Participants who had undergone orthodontic treatment; 4. Participants with any systemic and acute illness and under medication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Debri Index of Oral Hygiene Index Simplified and the Gingival Bleeding Index |
30,60 and 90days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of musical and manualtoothbrush - Debri Index of Oral Hygiene Index Simplified and the Gingival Bleeding Index |
30, 60 and 90 days |
|
|
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)
|
01/09/2016 |
| Date of Study Completion (India) |
23/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="15" |
|
Recruitment Status of Trial (Global)
|
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)?
|
|
Brief Summary
|
This study is a double – blind, parallel, randomized controlled trial study design was conducted for a period of 4 months to assess the change in the oral health status of children from 6 to 10 years of age among the musical toothbrush and manual toothbrush group. The primary outcome is to asses the Debri - Index of Oral Hygiene Index Simplified and the Gingival Bleeding Index of musical toothbrush group and to compare it with the manual toothbrush group at the time intervals of 30,60 and 90 days. |