| CTRI Number |
CTRI/2022/09/045332 [Registered on: 08/09/2022] Trial Registered Prospectively |
| Last Modified On: |
07/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
FOOD DEBRIS REMOVAL AND TOOTH BRUSH WEAR USING DIFFERENT BRUSHING METHODS |
|
Scientific Title of Study
|
COMPARING PLAQUE REMOVAL EFFICACY AND TOOTH BRUSH WEAR USING 2 DIFFERENT BRUSHING TECHNIQUES-A RANDOMIZED 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 |
ETTA VARUN |
| Designation |
POST GRADUATE STUDENT PUBLIC HEALTH DENTISTRY |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
Room number 2 Department of public health dentistry 1-2-64/1 Kothrepally opp Shiv Sagar lake Vikarabad Telangana 501102
Room number 2 Department of public health dentistry 1-2-64/1 Kothrepally opp Shiv Sagar lake Vikarabad Telangana 501102
Hyderabad
TELANGANA
501102
India |
| Phone |
8712345609 |
| Fax |
|
| Email |
ettavarun@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MONICA MOCHERLA |
| Designation |
HEAD OF THE DEPARTMENT - PUBLIC HEALTH DENTISTRY |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
Room number 2 Department of public health dentistry 1-2-64/1 Kothrepally opp Shiv Sagar lake Vikarabad Telangana 501102
Room number 2 Department of public health dentistry 1-2-64/1 Kothrepally opp Shiv Sagar lake Vikarabad Telangana 501102
Hyderabad
TELANGANA
501102
India |
| Phone |
8008882912 |
| Fax |
|
| Email |
docmonica81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ETTA VARUN |
| Designation |
POST GRADUATE STUDENT PUBLIC HEALTH DENTISTRY |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
Room number 2 Department of public health dentistry 1-2-64/1 Kothrepally opp Shiv Sagar lake Vikarabad Telangana 501102
Room number 2 Department of public health dentistry 1-2-64/1 Kothrepally opp Shiv Sagar lake Vikarabad Telangana 501102
Hyderabad
TELANGANA
501102
India |
| Phone |
8712345609 |
| Fax |
|
| Email |
ettavarun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri sai college of dental surgery |
|
|
Primary Sponsor
|
| Name |
Sri sai college of dental surgery |
| Address |
1-2-64/1 Kothrepally opp Shiv Sagar lake Vikarabad Telangana 501102 |
| 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 |
| Etta Varun |
Sri sai college of dental surgery |
1-2-64/1 Kothrepally opp Shiv Sagar lake Vikarabad Telangana 501102
Hyderabad
TELANGANA |
8712345609
ettavarun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive Intervention - teaching proper brushing technique |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brushing technique |
Group 1 Modified bass
Group 2 Comnination (leonards and fones)
Frequency- 2 times per day
Duration- 3 months
|
| Comparator Agent |
Control |
Regular brushing technique
Frequency- 2 times per day
Duration- 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Non-teaching staff with mild to moderate gingivitis / Good periodontal condition, Atleaste 18 natural teeth excluding third molars |
|
| ExclusionCriteria |
| Details |
Non-teaching with orthodontic treatment, having advanced periodontitis, smokers, pregnant, severe systemic illness, physically handicap, mental retardation, those using antibiotics, mouthwash, floss as regular oral hygiene aids and who are not willing to participate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PLAQUE AND TOOTH BRUSH WEAR these are the main outcomes used to determine the effects of the intervention |
First assesment-30 days,
Second assessment-60 days
Third assessment- 90 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Brushing daily twice |
30, 60 AND 90 DAYS |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/09/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
INTRODUCTION Regular and complete plaque removal is considered important for maintaining dental health. The American Dental Association recommends every 3 to 4 months, or sooner if the bristles become frayed as it leads to decrease in plaque removal efficiency. There is limited literature about extent of tooth brush wear in relation to various brushing techniques. OBJECTIVES OF STUDY: To compare plaque removal efficacy and tooth brush wear of 2 different brushing techniques. METHODOLOGY: A total of 90 non-teaching staff from dental institute will be included in this study. Individuals will be randomly assigned into 3 different groups through computer generated random numbers i.e., modified bass technique, combination (Leonards and fones) and a control group which follows their regular brushing technique. Baseline data will be recorded before oral prophylaxis. All the 3 groups will be provided with standard tooth brush and tooth paste. Plaque scores with Turesky Gilmore Index and Toothbrush Wear Index (WAI) through calibrated digital vernier caliper after 30days, 60days, 90days of post intervention will be recorded. Collected data will be subjected to normality tests, and frequencies will be derived for analysis. Based on distribution of data appropriate statistical tests will be done. |