| CTRI Number |
CTRI/2020/10/028629 [Registered on: 26/10/2020] Trial Registered Prospectively |
| Last Modified On: |
25/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of the cleaning efficiency of two toothbrushes |
|
Scientific Title of Study
|
Efficacy of short headed toothbrush: A clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Uma P Nair |
| Designation |
Post graduate |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
Room no. 9, Department of Periodontology, JSS Dental College and Hospital, JSS Academy of Higher Education and Research, Bannimantap
Mysore
KARNATAKA
570015
India |
| Phone |
8075530631 |
| Fax |
|
| Email |
umapn17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra |
| Designation |
Principal |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
Room no. 9, Department of Periodontology, JSS Dental College and Hospital, JSS Academy of Higher Education and Research, Bannimantap
Mysore
KARNATAKA
570015
India |
| Phone |
9481872469 |
| Fax |
|
| Email |
drsravindra@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Uma P Nair |
| Designation |
Post graduate |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
Room no. 9, Department of Periodontology, JSS Dental College and Hospital, JSS Academy of Higher Education and Research, Bannimantap
Mysore
KARNATAKA
570015
India |
| Phone |
8075530631 |
| Fax |
|
| Email |
umapn17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Study is conducted in JSS Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Curaden |
| Address |
Curaden AG
Based in Kriens near Lucerne
Switzerland |
| Type of Sponsor |
Other [Swiss-owned company] |
|
|
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 |
| Uma P Nair Principal investigator |
JSS Dental College and Hospital, JSS AHER |
Room No 9, Department of Periodontology, Bannimantap
Mysore
KARNATAKA |
08075530631
umapn17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Short headed toothbrush |
patients are asked to use the short headed toothbrush for 1 week |
| Comparator Agent |
standard toothbrush |
patients are asked to use the standard toothbrush for 1 week |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a full set of natural teeth excluding the third molars
Age up to 40 years
Patients who have GI score ≥ 1.5 and probing depth ≤ 5mm.
|
|
| ExclusionCriteria |
| Details |
Medically compromised
Smoking
Patients who have undergone periodontal treatment in the last 6 months.
Patients who have taken antibiotics in the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque index and Gingival index |
One week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index, Gingival index and patient satisfaction |
One month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2020 |
| Date of Study Completion (India) |
25/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This was a cross-over study, done to compare plaque removal capacity of 2 types of toothbrushes. A group 20 subject fulfilling the inclusion criteria and willing to participate was selected. They were divided into 2 groups of 10 participants each and were instructed to refrain from brushing for 24 hours and report to the Department of Periodontology. At baseline, the plaque index (PI) and gingival index (GI) was recorded. The subjects in group A was provided with regular standard toothbrush and subjects of group B was provided with the small headed toothbrush. No brushing instructions were given. They were advised to use the toothbrush for 1 week. After 1 week, again the clinical parameters was recorded. Then a washout period of 2 weeks was given. After the washout period, again the same group of participants were asked to refrain from brushing for 24 hours. The clinical parameters were assessed using the PI and GI. The subjects of group A were provided with the small headed toothbrush (CURADEN) and those of group B were provided with standard toothbrush. They were advised to use it for 1 week without any brushing instruments. After 1 week again all the clinical parameters were recorded. A questionnaire was also provided to record the patient’s preference and experience. The indices were recorded using mouth mirror and the Williams graduated periodontal probe. |