| CTRI Number |
CTRI/2021/10/037053 [Registered on: 04/10/2021] Trial Registered Prospectively |
| Last Modified On: |
15/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effectiveness of 3 different toothbrushes in children |
|
Scientific Title of Study
|
Effectiveness of plaque removal using different toothbrushes in children – a randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
OBUKAVITHA D |
| Designation |
Second year post graduate student |
| Affiliation |
KSR INSTITUTE OF DENTAL SCIENCE AND RESEARCH |
| Address |
Department of Pediatric and Preventive Dentistry - KSR Institute of Dental Science and Research. Tiruchengode
Namakkal
TAMIL NADU
637215
India |
| Phone |
8903744448 |
| Fax |
|
| Email |
obukavitha70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHARATH ASOKAN |
| Designation |
Principal |
| Affiliation |
KSR INSTITUTE OF DENTAL SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
KSR INSTITUTE OF DENTAL SCIENCE AND RESEARCH
TIRUCHENGODE
Tiruchengode - 637215.
Namakkal, TAMIL NADU
India
Namakkal
TAMIL NADU
637215
India |
| Phone |
9840168772 |
| Fax |
|
| Email |
asokansharath@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
OBUKAVITHA D |
| Designation |
Post graduate student |
| Affiliation |
KSR INSTITUTE OF DENTAL SCIENCE AND RESEARCH |
| Address |
Department of Pediatric and Preventive Dentistry - KSR Institute of Dental Science and Research. Tiruchengode
Namakkal
TAMIL NADU
637215
India |
| Phone |
8903744448 |
| Fax |
|
| Email |
obukavitha70@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nambiyur Primary union school |
|
|
Primary Sponsor
|
| Name |
OBUKAVITHA D |
| Address |
KSR Institute of Dental Science and Research |
| Type of Sponsor |
Other [Self sponsor] |
|
|
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 |
| V Naresh Kumar |
Panchayat Union primary school, Nambiyur |
Mettupalayam, Nambiyur. Block research teacher department , PUPS division,nambiyur main.
Erode
TAMIL NADU |
7550366428
dhana10teacher@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee KSR Institute of Dental Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy child aged from 6 to 8 years
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Toothbrush |
Colgate powered toothbrush. It should be replaced 3 months once and brushing duration is 2 minutes |
| Intervention |
Toothbrush |
Interactive toothbrush. It should be replaced 3 months once and brushing duration is 2 minutes |
| Comparator Agent |
Toothbrush |
Manual toothbrush. It should be replaced 3 months once and brushing duration is 2 minutes |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
-Physically and mentally healthy children
-Subjects who have never used any of the toothbrushes included in the study
-Children who are not using any other oral hygiene aids
-Children willing to participate in the study
-Children with a minimum of 16 teeth in their oral cavity
|
|
| ExclusionCriteria |
| Details |
-Children with gingival/periodontal diseases and/ or oral ulcers
-Any physical condition that limits manual dexterity required for toothbrushing
-History of medications for the past 3 months that could affect the oral health
-Patient wearing fixed orthodontic appliances, removable dentures.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the effectiveness of plaque removal using three different toothbrushes. |
3 and 6 months follow-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the degree of wear and distribution of bite mark in 3 toothbrushes. |
3 months |
| Patient acceptance of toothbrushes. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/10/2021 |
| Date of Study Completion (India) |
09/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
09/12/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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)
|
The effectiveness of different types of toothbrushes on plaque removal in 6 to 8-year school-going children will be assessed using the Turesky modification of Quigley and Hein Index. After getting permission from schools, screening of school children for population selection. Children were selected based on the inclusion criteria. Only children had dmft score less than or equal to 2 and children should not use any of the study toothbrushes for oral hygiene measures. 75 children were included after getting informed consent from their parents. Baseline data were evaluated after one week of oral prophylaxis. 75 children were randomly allocated to 3 groups. Group I were received conventional toothbrushes; Group II were received powered toothbrushes; Group III were received MagiK interactive toothbrushes. Post intervention data collection was done at 15th day, 30th day, 45th day and finally 90th day. Data collected were plaque score, toothbrush wear and bite mark score according to the criteria given by corforti et al in 2003. Patient preferred toothbrush were evaluated by distributing the questionnaire at 90th day follow up. Data collected were subjected to statistical analysis |