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CTRI Number  CTRI/2024/05/066578 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 27/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Curved bristles toothbrush for improved oral hygiene in children 
Scientific Title of Study   Evaluation of an innovative curved bristles toothbrush in dental plaque removal and on gingival health in children 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Diksha Patil 
Designation  Post graduate student 
Affiliation  D Y Patil University School of Dentistry 
Address  Department of Pediatric and Preventive dentistry, Basement, D Y Patil University School of dentistry, Sector 7, D Y Patil Vidyanagar, Nerul, Navi Mumbai,Thane,MAHARASHTRA,400706,India

Thane
MAHARASHTRA
400706
India 
Phone  8286686912  
Fax    
Email  diksha.d.patil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jasmin Winnier 
Designation  Associate Professor 
Affiliation  D Y Patil University School of Dentistry 
Address  Department of Pediatric and Preventive dentistry, Basement, D Y Patil University School of dentistry, Sector 7, D Y Patil Vidyanagar, Nerul, Navi Mumbai,Thane,MAHARASHTRA,400706,India

Thane
MAHARASHTRA
400706
India 
Phone  9773284371  
Fax    
Email  jasmin.winnier@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Jasmin Winnier 
Designation  Associate Professor 
Affiliation  D Y Patil University School of Dentistry 
Address  Department of Pediatric and Preventive dentistry, Basement, D Y Patil University School of dentistry, Sector 7, D Y Patil Vidyanagar, Nerul, Navi Mumbai,Thane,MAHARASHTRA,400706,India

Thane
MAHARASHTRA
400706
India 
Phone  9773284371  
Fax    
Email  jasmin.winnier@dypatil.edu  
 
Source of Monetary or Material Support  
D.Y.Patil university School of Dentistry Navi Mumbai 
 
Primary Sponsor  
Name  DY Patil University School of dentistry Department of Pediatric and Preventive dentistry 
Address  Department of Pediatric and Preventive Dentistry DY Patil University School of dentistry, Dr. D.Y.Patil Vidyanagar,Sector 7, Nerul, Navi Mumbai 
Type of Sponsor  Private medical college 
 
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 
Dr Jasmin Winnier  D Y Patil University School of Dentistry, Navi Mumbai  Post Graduate Clinic, Department of Pediatric and preventive dentistry, Basement. Dr DY Patil Vidyanagar, sector 7, Nerul, Navi Mumbai,Thane,MAHARASHTRA
Thane
MAHARASHTRA 
9773284371

jasmin.winnier@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethical Board, DY Patil University School of Dentistry, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Typically developing 8-10 years old children 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Collis curve toothbrush  Twice daily toothbrushing using Collis curve toothbrush for 3 weeks 
Comparator Agent  Conventional manual toothbrush  Twice daily toothbrushing using conventional manual toothbrush for 3 weeks 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Children without any systemic diseases
2. Children with normal motor and cognitive development
3. Children who brush their teeth twice daily
4. Children using no other means of oral hygiene except tooth brushing 
 
ExclusionCriteria 
Details  1. Children with history of antibiotic therapy in past one-month
2. Children who have undergone oral prophylaxis in past one-month
3. Children with deep carious lesions and fixed orthodontic appliances
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Plaque removal efficacy using-Turesky’s modification of Quigley Hein plaque index
2.Gingival health using Loe and Silness Gingival index

 
At baseline and after 3 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/05/2024 
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="0"
Days="21" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Introduction:

Effective toothbrushing allows removal of dental biofilm, reducing the risk for dental caries and gingivitis. Factors influencing effective toothbrushing in children include correct toothbrushing methods, frequency, duration and toothbrush design. Several modifications of manual toothbrushes are developed to enhance mechanical removal of dental biofilm in children. The basic shape of manual toothbrushes remains same, while minor changes in handle design, bristle material and arrangement have been studied extensively. Recently, a toothbrush with an innovative bristle design has been introduced, claiming to efficiently remove plaque and reduce gingival inflammation.

Aim:

To evaluate plaque removal efficacy and gingival health using Collis curve toothbrush in comparison to conventional manual toothbrush in children between age 8 and 10 years.

Methodology:

A randomized controlled trial of 60 children between age 8 and 10 years who had good systemic health, normal motor and cognitive development and twice daily toothbrushing habit were included. DMFT was recorded for each child. Gingival scores and plaque scores were recorded using Loe and Silness gingival index and Turesky’s modification of Quigley and Hein plaque index (TQHI). The selected children were randomly assigned to manual toothbrush group (MT) and Collis curve toothbrush group (CT). They were instructed to use the respective toothbrushes for a duration of 3 weeks after which gingival index and plaque index were re-recorded. The mean score difference was used to determine the gingival health and plaque removal efficacy of the respective toothbrushes.

 
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