| CTRI Number |
CTRI/2023/09/057334 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
24/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Egg Carton Simulation method as a method of teaching tooth brushing among school going children |
|
Scientific Title of Study
|
Effectiveness Of Egg Carton Simulation Model as a Method of teaching tooth brushing in School going children- A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sugeethika polapala |
| Designation |
Post Graduate Student |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Room no 5, Department of Public Health Dentistry, Anil Neerukonda Institute of Dental sciences, Sangivalasa, Visakhapatnam.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9493126374 |
| Fax |
|
| Email |
sugeethika.p97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Vamsi Krishna Reddy |
| Designation |
Professor and Head of Department |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Room no 5, Department of Public Health Dentistry,Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Visakhapatnam.
Department of Public Health Dentistry,Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Visakhapatnam.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9908200033 |
| Fax |
|
| Email |
principal.anids@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sugeethika polapala |
| Designation |
Post Graduate Student |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Room no 5, Department of Public Health Dentistry,Anil Neerukonda Institute of Dental sciences, Sangivalasa, Visakhapatnam.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9493126374 |
| Fax |
|
| Email |
sugeethika.p97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil Neerukonda Institute of Dental Sciences,Sangivalasa,Bheemunipatnam, Visakhapatnam |
|
|
Primary Sponsor
|
| Name |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Room no 5, Department of Public Health Dentistry, Anil Neerukonda institute of dental sciences, visakhapatnam |
| Type of Sponsor |
Private medical college |
|
|
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 Sugeethika polapala |
Anil Neerukonda Institute of Dental Sciences |
Room no 5, Department of Public Health Dentistry,Sanivalasa, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH |
9493126374
sugeethika.p97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-Anil Neerukonda Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening interventions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Health Education on Egg Carton Model |
Oral Health Education demonstration on Egg carton model and plaque scores were assessed after 21 days to children and in the other group tooth brushing is demonstrated using tooth brushing model |
| Comparator Agent |
Oral Health Education on Tooth Brushing Model |
tooth brushing is demonstrated on tooth brushing model in another group and plaque scores were assessed after 21 days |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children must understand and communicate in either English or Telugu. |
|
| ExclusionCriteria |
| Details |
•Children with special needs.
• Children with active systemic/oral disease
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque scores |
Baseline, 21 days, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oral health status & plaque scores |
Baseline, 21 days, 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study is to develop a novel activity-based tooth brushing teaching method for school children using egg cartons as simulated teeth models and evaluate the effectiveness of the same. Two methods of teaching tooth brushing technique to school children of age 8 to 12years were compared through a Randomized Control Trial.: (i) Conventional method (N=15): Instructions on study model (ii) Egg carton simulation method (N=15): Hands-on activity on egg cartons as simulated models. The outcome assessed was the plaque index (Silness and Loe, 1964). Gender-wise comparisons were done using a chi-square test for comparing the categorical variables. Plaque scores compared using an independent t-test showed significant improvement in the egg carton group after the teaching sessions (P<0.01 for the egg carton method).Hence to conclude, The egg carton simulation method is an effective method for plaque removal compared to the conventional approach as there is significant plaque score reduction in children after the teaching session. |