| 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
|
|
|
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
|
|
|
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. |