| CTRI Number |
CTRI/2022/02/040616 [Registered on: 25/02/2022] Trial Registered Prospectively |
| Last Modified On: |
10/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of various mechanical oral hygiene aids(like toothbrush,fingerbrush) among toddlers(2 to 3 yrs old children) in Chennai
-A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effectiveness of various mechanical oral hygiene aids among toddlers in Chennai
-A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARANYASRI S |
| Designation |
MDS POSTGRADUATE STUDENT |
| Affiliation |
THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL,CHENNAI-600003 |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY,ROOM NUMBER:G-3,THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL,OPPOSITE TO FORT STATION,MUTHUSWAMY SALAI,CHENNAI-600003. PHONE NUMBER-9791509571
Chennai
TAMIL NADU
600003
India |
| Phone |
|
| Fax |
|
| Email |
drssaranyasri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAMESH KUMAR S G |
| Designation |
SENIOR ASSISTANT PROFESSOR |
| Affiliation |
THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL,CHENNAI-600003 |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY,ROOM NUMBER:G-3,THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL,OPPOSITE TO FORT STATION,MUTHUSWAMY SALAI,CHENNAI-600003. PHONE NUMBER:9840792950
Chennai
TAMIL NADU
600003
India |
| Phone |
|
| Fax |
|
| Email |
ramesh172000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SARANYASRI S |
| Designation |
MDS POSTGRADUATE STUDENT |
| Affiliation |
THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL,CHENNAI-600003 |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY,ROOM NUMBER:G-3,THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL,OPPOSITE TO FORT STATION,MUTHUSWAMY SALAI,CHENNAI-600003. PHONE NUMBER-9791509571
Chennai
TAMIL NADU
600003
India |
| Phone |
|
| Fax |
|
| Email |
drssaranyasri@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PUBLIC HEALTH DENTISTRY,ROOM NUMBER:G-3,THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL,OPPOSITE TO FORT STATION,MUTHUSWAMY SALAI,CHENNAI-600003. |
|
|
Primary Sponsor
|
| Name |
SARANYASRI S |
| Address |
THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL,CHENNAI-600003 |
| Type of Sponsor |
Other [SELF FUNDING] |
|
|
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 SARANYASRI S |
THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY,ROOM NUMBER:G-3,THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL,OPPOSITE TO FORT STATION,MUTHUSWAMY SALAI,CHENNAI-600003
Chennai
TAMIL NADU |
9791509571
drssaranyasri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL REVIEW BOARD ,THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TOOTH BRUSH,FINGER BRUSH,GUAZE CLOTHE,TOOTH WIPES |
After baseline plaque score recording, the randomisation of the study participants to the 4
different intervention groups (TB (tooth brush group), FB (finger brush group), GC (gauze
clothe group), and TW (tooth wipes group) will be done by providing Sequentially numbered,
opaque, sealed envelope (SNOSE) technique by the co-investigator and the chief investigator
is blinded to the intervention group the participants are allocated.
The co-investigator provides the parent with the necessary oral hygiene aids viz. tooth
brush or finger brush or gauze cloth or tooth wipes. Oral hygiene instructions regarding how
to use the mechanical oral hygiene aids is explained to the parents using preformed, pretested
audio-visual aid. The study participants are reviewed after 14 days and post intervention plaque
score is recorded by the chief investigator. Compliance, ease of use and parents’ opinion
regarding the usage of the mechanical aid will be obtained using a pretested, customised
questionnaire. |
| Comparator Agent |
TOOTHBRUSH |
After baseline plaque score recording, the randomisation of the study participants to the 4 different intervention groups (TB (tooth brush group), FB (finger brush group), GC (gauze clothe group), and TW (tooth wipes group) will be done by providing Sequentially numbered, opaque, sealed envelope (SNOSE) technique by the co-investigator and the chief investigator is blinded to the intervention group the participants are allocated. The co-investigator provides the parent with the necessary oral hygiene aids viz. tooth brush or finger brush or gauze cloth or tooth wipes. Oral hygiene instructions regarding how to use the mechanical oral hygiene aids is explained to the parents using preformed, pretested audio-visual aid. The study participants are reviewed after 14 days and post intervention plaque score is recorded by the chief investigator. Compliance, ease of use and parents’ opinion regarding the usage of the mechanical aid will be obtained using a pretested, customised questionnaire |
|
|
Inclusion Criteria
|
| Age From |
24.00 Month(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
1. Toddlers of age 24 to 36 months with normal developmental milestones.
2. Have at least four incisors and 1st primary molar erupted.
3. Toddlers scoring two to five in the Diet questions (Question no:13) of “WHO Oral
Health Questionnaire for Children†(2013) |
|
| ExclusionCriteria |
| Details |
Toddlers with
1. Systemic illness
2. Developmental anomalies
3. Rampant carieS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plaque score using Turesky -Gilmore-Glickman Modified Quigley-Hein Plaque
Index (TQHPI) |
14TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compliance and acceptance of using oral hygiene aid |
14th day |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The role of the accumulation of dental plaque in the development of dental caries and
periodontal diseases is well established. Dental plaque is considered as one of the risk factor
for caries in infants, toddlers and preschool children, mainly early childhood caries (ECC).So Toothbrushing should start as soon as the first teeth erupts into oral cavity. Various
tooth cleaning aids like Toothbrushes of small sizes, finger toothbrush ,tooth and gum
wipes are commercially available for the mothers to brush their child’s teeth.The aim of the present study is to evaluate the effectiveness of tooth wipes, gauze cloth,
finger brush and manual toothbrush in removing dental plaque among the toddlers visiting
various Play Schools and Child Day Care Centres in Chennai employing Randomized
Controlled trial design.The sample comprising of toddlers aged 24 months to 36 months based on inclusion
and exclusion criteria will be recruited from various Play Schools and Child Day Care Centres
in Chennai by Multistage random sampling. Sample size is determined to be 36 in each group
using the effect size calculated from previous study, Effectiveness of Tooth Wipes in
Removing Babies’ Dental Biofilm by Abanto et al in 2012. Prior to recruitment, information
regarding the study will be given to parents of the children and written informed consent will
be obtained. Based on inclusion and exclusion criteria a total of 144 participants will be
recruited to the randomised controlled trial. Prior to intervention the chief investigator will
assess the baseline plaque score (Turesky -Gilmore-Glickman Modified Quigley-Hein Plaque
Index (TQHPI) using disclosing agent) for all participants.
All teeth will be assessed and the plaque revealed on the buccal and lingual surfaces of
the teeth are given scores on a scale of 0 to 5, An index for the entire mouth is determined by
dividing the total score by the number of surfaces examined.After baseline plaque score recording, the randomisation of the study participants to the 4
different intervention groups (TB (tooth brush group), FB (finger brush group), GC (gauze clothe group), and TW (tooth wipes group) will be done by providing Sequentially numbered,
opaque, sealed envelope (SNOSE) technique by the co-investigator and the chief investigator
is blinded to the intervention group the participants are allocated.
The co-investigator provides the parent with the necessary oral hygiene aids viz. tooth
brush or finger brush or gauze cloth or tooth wipes. Oral hygiene instructions regarding how
to use the mechanical oral hygiene aids is explained to the parents using preformed, pretested
audio-visual aid. The study participants are reviewed after 14 days and post intervention plaque
score is recorded by the chief investigator. Compliance, ease of use and parents’ opinion
regarding the usage of the mechanical aid will be obtained using a pretested, customised
questionnaire.The data management and data analysis will be done using SPSS software version 21.
Paired t test will be used to test the effectiveness of individual mechanical plaque control aid.
ANOVA test will be used to compare the difference in effectiveness of the mechanical plaque
control aids followed by post-hoc test |