| CTRI Number |
CTRI/2023/11/059647 [Registered on: 08/11/2023] Trial Registered Prospectively |
| Last Modified On: |
07/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Tooth Brush] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of different herbal infused tooth brush on gingival health. |
|
Scientific Title of Study
|
Comparison of Plaque Removal, Wear Index and salivary parameters among tulsi Infused, eugenol infused and Nylon Toothbrushes: A Randomized Control trial. |
| 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 Yoga Abirami S |
| Designation |
Post Graduate |
| Affiliation |
Tamilnadu Dr MGR Medical University |
| Address |
Department of Public Health Dentistry, Karpaga Vinayaga Institute of Dental Sciences,GST ROAD, CHINNA KOLAMBAKKAM, · PALAYANOOR (PO), · CHENGALPATTU (DT)· MADHURANTHAGAM(TK),
Kancheepuram
TAMIL NADU
603 308
India |
| Phone |
7010775046 |
| Fax |
|
| Email |
dryogaabirami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VISHNU PRASAD S |
| Designation |
Head and Professor |
| Affiliation |
Tamilnadu Dr MGR Medical University |
| Address |
Department of Public Health Dentistry, Karpaga Vinayaga Institute of Dental Sciences,GST ROAD, CHINNA KOLAMBAKKAM, · PALAYANOOR (PO), · CHENGALPATTU (DT)· MADHURANTHAGAM(TK),
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9894720548 |
| Fax |
|
| Email |
vishnumds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yoga Abirami S |
| Designation |
Post Graduate |
| Affiliation |
Tamilnadu Dr MGR Medical University |
| Address |
Department of Public Health Dentistry, Karpaga Vinayaga Institute of Dental Sciences,GST ROAD, CHINNA KOLAMBAKKAM, · PALAYANOOR (PO), · CHENGALPATTU (DT)· MADHURANTHAGAM(TK),
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7010775046 |
| Fax |
|
| Email |
dryogaabirami@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [No sponsor ] |
|
|
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 Yoga Abirami S |
Karpaga Vinayaga Institute of Dental Science |
3rd floor, Department of Public Health Dentistry, GST ROAD, CHINNA KOLAMBAKKAM, PALAYANOOR (PO)
Kancheepuram
TAMIL NADU |
7010775046
dryogaabirami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- karpaga vinayaga institute of dental science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health human volunteers
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
eugenol infused tooth brush |
this is a herbal infused tooth brush, used twice daily for 6 months |
| Comparator Agent |
Nylon Toothbrushes |
this is a control group this intervention was used twice daily for 6 months |
| Intervention |
Tulsi Infused tooth brush |
These is herbal infused tooth brushes used as intervention.
use for twice daily for the duration of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy participants above 18 years of age.
Participants having 20 or more permanent teeth.
Participants with visible deposits.
|
|
| ExclusionCriteria |
| Details |
Participants with gingival or periodontal disease.
Participants wearing orthodontic or prosthetic appliances.
Participants currently on antimicrobials or analgesics.
Participants who reported tobacco use in any form.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque Removal, Wear Index & salivary ph, salivary flow rate |
Baseline & 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
01/12/2023 |
| 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="0"
Months="1"
Days="12" |
|
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
|
this study is to analyse the effect of three different tooth brushes, in plaque removal and salivary parameters |