| CTRI Number |
CTRI/2025/09/095187 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study on dental floss in gum swelling and teeth health |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of Compact Dental Water Flosser in gingival and teeth health A Prospective randomized, open label, blinded end point assessor (PROBE) clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WF GTH 2025 1, Version 1.0, 12th May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Juhi Gundavda |
| Designation |
Associate Professor |
| Affiliation |
D. Y. Patil Deemed to be University School of Dentistry |
| Address |
Department of Periodontics and oral Implantology
Fifth Floor, OPD No.1
D. Y. Patil Deemed to be University School of Dentistry,
Nerul, Navi Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9819625771 |
| Fax |
|
| Email |
dr.juhigundavda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd A wing 402 A, B, C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd A wing 402 A, B, C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| GuruNanda LLC, 6645
Caballero Blvd. Buena Park,
CA 90620
|
|
|
Primary Sponsor
|
| Name |
GuruNanda LLC |
| Address |
6645 Caballero Blvd. Buena Park,
CA 90620
|
| Type of Sponsor |
Other [Global Healthcare Industry] |
|
|
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 Juhi Gundavda |
D. Y. Patil Deemed to be University School of Dentistry |
Department of Periodontics and oral Implantology
Fifth Floor, OPD No.1
D. Y. Patil Deemed to be University School of Dentistry,
Nerul, Navi Mumbai, Maharashtra 400706
Mumbai (Suburban)
MAHARASHTRA |
9819625771
dr.juhigundavda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethical Board, D.Y. Patil University school of Dentistry, Nerul Navi Mumbai-4100704 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Toothbrush with an ADA Accepted Fluoride dentifrice |
Participant will be asked to use Toothbrush with an ADA Accepted Fluoride dentifrice twice daily for 30 days |
| Intervention |
Toothbrush with an ADA Accepted Fluoride dentifrice with additional use of the water flosser |
Participant will be asked to use toothbrush with an ADA Accepted Fluoride dentifrice twice daily with additional use of the Compact Dental Water Flosser once daily for 30 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants without loss of interproximal clinical periodontal attachment, with papilla completely filling the interproximal space, and with at least 24 teeth
2.Qualified participants should present with Gingival Index score 2 and more than 15 percent of the interproximal sites, excluding posterior distal sites excluded.
3.Willing to comply with all requirements of the study including post treatment care and attending all treatment and follow up visits.
|
|
| ExclusionCriteria |
| Details |
1.Vulnerable population, impacting the study outcomes
2.Participants with xerostomia, orthodontic appliances, requiring antimicrobial prophylaxis
3. Known cases of diabetics, smokers. known psychomotor disorders
4. Participants having used antibiotics/anti-inflammatory agents within the last 1 month
5. Known hypersensitivity high pressure dental cleaning as per the investigator
6. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in severity of Gingivitis |
Day 0, Day 15 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in dental plaque
2. Change in oral health
3. Assessment of teeth and gingival tissue
4. Global assessment of overall change by the investigator and Participant
5. Assessment of adverse events and adverse drug reactions including vitals
|
Day 0, Day 15 and Day 30 |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/10/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It
is a clinical study to evaluate
efficacy and safety of Compact Dental Water Flosser in gingival and teeth
health. The study will be carried out at 1 to 2 centers in India. As per
computer generated randomization list, participants will
be randomized either to Compact Dental Water Flosser Group or Control Group in
1:1 ratio. Participant will be asked to use either toothbrush with an ADA
Accepted Fluoride dentifrice twice daily with additional use of the Compact
Dental Water Flosser once daily or Toothbrush with an ADA Accepted Fluoride dentifrice
twice daily for 30 days. The primary objective of the study will be to assess change in severity of Gingivitis. Secondary objectives of the study
will be to assess change in dental plaque, change in oral health, teeth and
gingival tissue, overall change by the investigator and participant and adverse
events and adverse drug reactions including vitals on day 0, day 15 and day 30 |