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CTRI Number  CTRI/2023/03/051137 [Registered on: 28/03/2023] Trial Registered Prospectively
Last Modified On: 23/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Novel tooth brushing training system and method for children 
Scientific Title of Study   Comparative evaluation of novel tooth brushing with reminder therapy with conventional tooth brushing techniques in children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpa S 
Designation  Postgraduate Student 
Affiliation  M R Ambedkar Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry Room no 7 2nd floor M R Ambedkar Dental College and Hospital 1 36 CLINE ROAD COOKE TOWN BENGALURU 560005

Bangalore
KARNATAKA
560005
India 
Phone  08971091990  
Fax    
Email  rangneela@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyothsna V Setty 
Designation  Professor 
Affiliation  M R Ambedkar Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry Room no 7 2nd floor M R Ambedkar Dental College and Hospital 1 36 CLINE ROAD COOKE TOWN BENGALURU 560005

Bangalore
KARNATAKA
560005
India 
Phone  9449819468  
Fax    
Email  jyothsnasrikanth@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyothsna V Setty 
Designation  Professor 
Affiliation  M R Ambedkar Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry Room no 7 2nd floor M R Ambedkar Dental College and Hospital 1 36 CLINE ROAD COOKE TOWN BENGALURU 560005

Bangalore
KARNATAKA
560005
India 
Phone  9449819468  
Fax    
Email  jyothsnasrikanth@gmail.com  
 
Source of Monetary or Material Support  
M R Ambedkar Dental College and Hospital 1/36 Cline road Cooke town Bangalore- 560005 
 
Primary Sponsor  
Name  Dr Shilpa S 
Address  17 14th Cross Cubbonpet Bangalore 560002 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
M R Ambedkar Dental College and Hospital  1/36 CLINE ROAD COOKE TOWN BENGALURU- 560005  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shilpa  Devangha Sangha primary and high school  Principal office 2nd floor Devangha Sangha primary and High school No 11/3 7th cross Devangha Sangha road Opposite Geo hotel Sampangi Rama nagar Bengaluru
Bangalore
KARNATAKA 		 8971091990

rangneela@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe M R Ambedkar Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  The subjects are provided with standard tooth paste and tooth brush and asked to continue brushing in the same way and are reinforced to brush twice daily 
Comparator Agent  Tooth brushing using Fones technique  The subjects are asked to brush their teeth using the fones technique that is using the circular motion 
Intervention  Tooth brushing with reminder therapy Dantharaag the tooth tune  The subjects are asked to brush starting from the right posterioe region then the anterior and the the left posterior region in circular motion by keeping the bristles at an angle of 80 degrees they are also to brush on the occlusal surface and the lingual surface while recieting in their mind ON THE TOOTH IN THE SPACES 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1 Subjects aged between 6-12 years.
2 Subjects with no physical and systemic illness
3 Subjects willing to take part in the study
 
 
ExclusionCriteria 
Details  1 Medically compromised children and children with special care needs
2 Subjects undergoing any surgical treatment
3 Children below 6 years and above 12 years
4 Subjects who are not physically and mentally fit
5 Patients whose parents/guardian/head of institution have not consented for permission
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The plaque removal efficacy and effectiveness of the Novel technique  baseline plaque score gingival score oral hygiene score and DMFT
15 days plaque score gingival score oral hygiene score and DMFT
45 days plaque score gingival score oral hygiene score and DMFT
3 months plaque score gingival score oral hygiene score and DMFT
6 months plaque score gingival score oral hygiene score and DMFT
12 months plaque score gingival score oral hygiene score and DMFT
18 months plaque score gingival score oral hygiene score and DMFT  
 
Secondary Outcome  
Outcome  TimePoints 
reduction in tooth caries  baseline plaque score gingival score oral hygiene score and DMFT
15 days plaque score gingival score oral hygiene score and DMFT
45 days plaque score gingival score oral hygiene score and DMFT
3 months plaque score gingival score oral hygiene score and DMFT
6 months plaque score gingival score oral hygiene score and DMFT
12 months plaque score gingival score oral hygiene score and DMFT
18 months plaque score gingival score oral hygiene score and DMFT  
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   06/04/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Dental caries and periodontal diseases are the most prevalent oral diseases in children. Oral hygiene practices are not performed up to mark in most of the children because of various reasons leading to dental caries and other periodontal diseases. Dental plaque is one of the common causative agent for oral diseases. Effectiveness of tooth brushing depends on the use of proper tooth brushing technique, which is often difficult in children. There are various brushing techniques specially designed for children which help them to perform proper tooth brushing. The popular tooth brushing technique in children horizontal scrub and Fones technique. Though these are regularly used by the children, they still lack in providing an 100% effective oral hygiene maintenance. Often, it is noted that certain areas of the oral cavity are brushed more while the other areas are neglected. A child’s mind is mouldable and training a child’s mind in proper tooth brushing can in turn improve their oral hygiene and their general health. With this background, we have designed a novel technique of tooth brushing with reminder therapyThis is a pilot study comparing a novel tooth brushing technique combined with reminder therapy with other standard techniques in paediatric dentistry.
The study will be conducted in an educational institution. After obtaining permission from the Institutional head and informed consent from the parents the study will be carried on. 

The study will begin with the oral examination of the study participants. A disclosing agent like Alpha Plac® will be applied on the tooth surfaces before recording the indices.Oral Hygiene Index Simplified (OHI-S), Turesky-Gilmore-Glickman modification of Quigley-Hein Plaque Index (TMQH), Modified Gingival Index(MGI), DMFT and DMFS indices will be recorded. All the study participants will be provided with a standard tooth paste and tooth brush.

Group 1 participants will be asked to brush in the same way and will be reinforced to brush twice daily using the tooth paste and brush provided to them and no new technique will be taught to them.

Group 2 participants will be shown a video of Brushing using Fones technique and the same will be demonstrated live on a model.

Group 3 participants will be shown a video of brushing along with the reminder (Dantharaag- The Tooth Tune), where they are asked to start brushing from the right posterior tooth region, continuing to the anterior and then the left posterior region in circular motion. The participants are instructed to brush on the occlusal surfaces and the lingual surfaces will reciting in their mind “ON THE TOOTH IN THE SPACES” and the same will be demonstrated live on a model.

Follow up will be done at 15 days, 45 days, 3 months and 6 months.

 
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