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CTRI Number  CTRI/2018/02/012182 [Registered on: 27/02/2018] Trial Registered Retrospectively
Last Modified On: 23/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to compare two types of toothbrushes, normal and battery toothbrushes in reduction of gum disease. 
Scientific Title of Study   Comparison of effectiveness of Manual and Powered toothbrushes in reduction of plaque and gingivitis -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  Pichika Swathi 
Designation  Post graduate student  
Affiliation  Rajiv Gandhi University of Health Sciences 
Address  Department of Public Health Dentistry, The Oxford Dental College and Hospital, Bommanahalli,Bangalore

Bangalore
KARNATAKA
560068
India 
Phone  8790253269  
Fax    
Email  pichika.swathi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjunath C 
Designation  Professor 
Affiliation  The Rajiv Gandhi University of Health Sciences, Bangalore 
Address  Department of Public Health Dentistry, The Oxford Dental College and Hospital, Bommanahalli,Bangalore

Bangalore
KARNATAKA
560068
India 
Phone  9742203022  
Fax    
Email  drmanjunathphd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pichika Swathi 
Designation  Post graduate student  
Affiliation  Rajiv Gandhi University of Health Sciences 
Address  Department of Public Health Dentistry, The Oxford Dental College and Hospital, Bommanahalli,Bangalore

Bangalore
KARNATAKA
560068
India 
Phone  8790253269  
Fax    
Email  pichika.swathi@gmail.com  
 
Source of Monetary or Material Support  
Department of Public Health Dentistry, The Oxford Dental College, 10th milestone, Hosur road, Bommanahalli, Bangalore - 560068. 
 
Primary Sponsor  
Name  Pichika Swathi 
Address  Department of Public Health Dentistry, The Oxford Dental College, Bommanahalli, Bangalore 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
PichikaSwathi  The Oxford Dental College  Department of Public Health Dentistry, The Oxford Dental College and Hospital, Bommanahalli,Bangalore
Bangalore
KARNATAKA 		 8790253269

pichika.swathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, The Oxford Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gingivitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Manual toothbrush [Oral-B Pro Health-soft]  Group-A:subjects using manual toothbrush,twice daily for 6 months.  
Intervention  Powered toothbrush [Oral-B Cross Action]  Group B - subjects using powered toothbrush, twice daily for 6 months. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1)Good general health.
2)No history of periodontal therapy during the past 3 months.
3)Full complement of teeth present, except third molars.
 
 
ExclusionCriteria 
Details  1)Use of any antibiotics that could affect the state of the gingival tissues.
2)Who are undergoing or planning to undergo orthodontic treatment.
3)Subjects with multiple prosthesis.
4)Subjects who are already using powered toothbrushes.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Gingival Index(Loe and Sillness),(range:0-3)
2)Plaque Index (Loe and Sillness), (range:0-3) 		 7th day, 14th day, 45th day, 3rd month, 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the plaque score.  6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   07/12/2017 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

AIM OF THE STUDY:

To assess the effectiveness of manual and powered toothbrushes in controlling plaque and gingivitis among dental students of The Oxford Dental college and Hospital, Bengaluru.

OBJECTIVE OF THE STUDY:

To assess and to compare the effectiveness of manual and powered toothbrushes in the reduction of plaque and gingivitis over a period of six months.

SOURCE OF DATA:

First and second year B.D.S students of The Oxford Dental College and Hospital, Bengaluru.

STUDY DESIGN:

The study design will be Single blinded randomized controlled trial (RCT). The sample size consists of 50 dental students (first and second year B.D.S) of both the genders.
The subjects will be randomly divided into two groups  (Group –A and group –B) by a second investigator using a lottery method  and brushing technique will be demonstrated and instructed to brush twice a day for 2 minutes (once in the morning and once during night before sleeping). 
Baseline scores will be recorded and scaling and polishing will be done for all the subjects.
Group –A will be consisting of 25 subjects and will be given manual toothbrushes [Oral-B Pro Health-soft] and will be instructed to use Modified Bass method of brushing technique. 
Group- B will be consisting of 25 subjects and will be given powered toothbrushes [Oral-B Crossaction] and will be instructed to use the brush with the bristles perpendicular to gingival margin or sulcus.

Subjects will be recalled at 7th, 14th, 45th day, 3rd month and 6th month. 
The gingival scores will be recorded by a blinded assessor using Loe and Silness (1963) gingival index and the amount of plaque using Loe and Silness plaque index (1964) after using a Disclosing agent (two-tone). 

 
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