| CTRI Number |
CTRI/2025/06/089601 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Evaluation Of Water Flosser and Dental Floss in Gingival Health Maintenance - A Randomized Controlled Trial |
|
Scientific Title of Study
|
Comparative Evaluation Of Water Flosser and Dental Floss in Gingival Health Maintenance- A Randomized Controlled 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 |
BACCHU VENKATA SUSHMA |
| Designation |
STUDENT |
| Affiliation |
Lenora institute of dental sciences |
| Address |
Department of periodontics,
KLR Lenora dental college,
Rajanagaram, rajahmundry.
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
7093448497 |
| Fax |
|
| Email |
bvsushma951@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N.SOWMYA REDDY |
| Designation |
LECTURER |
| Affiliation |
Lenora institute of dental sciences |
| Address |
Department of peridontics,Klr lenora dental college.
Rajanagaram, rajahmundry.
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
7093448497 |
| Fax |
|
| Email |
sowmyareddy848@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BACCHU VENKATA SUSHMA |
| Designation |
STUDENT |
| Affiliation |
Lenora institute of dental sciences |
| Address |
Department of periodontics,Klr lenora dental college.
Rajanagaram, rajahmundry.
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
7093448497 |
| Fax |
|
| Email |
bvsushma951@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded- Dr.BACCHU VENKATA SUSHMA,Department of periodontics,lenora dental college. |
|
|
Primary Sponsor
|
| Name |
BACCHU VENKATA SUSHMA |
| Address |
Dr.BACCHU VENKATA SUSHMA,Department of periodontics,lenora dental college.
533294 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Haiti |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| BACCHU VENKATA SUSHMA |
Maxillary mandibular supragingival area |
Department of periodontics,
KLR Lenora dental college.
East Godavari
ANDHRA PRADESH |
7093448497
bvsushma951@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients who had mild to moderate gingival inflammation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy gingivitis patients
-age group 18-50 years
-patient with fair to poor oral hygiene, minimum of 20 scorable teeth excluding 3rd molars
-patient who were willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
Systemically compromised individuals
-patient who are smokers
- periodontitis patients
-Patient who are not willing to give informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to evaluate the effectiveness of flossing methods in reducing the clinical signs of inflammation in gingivitis patients (gingival bleeding and supragingival plaque).
|
baseline,2weeks,4weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of water flosser on reduction of the gingival inflammation in gingivitis patients.
2. To evaluate the efficacy of water flosser over manual flossing in oral hygiene maintenance
|
at baseline,2weeks,4weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/07/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Background: Effective plaque control is pivotal in managing and reversing gingival inflammation. While traditional dental floss has been the gold standard for interdental cleaning, its been highly technique sensitive, resulting in patient self-harm if not used in the proper way leading to more periodontal tissue damage. The water flossers have emerged as a modern alternative to manual flossing. This study aimed to compare the impact of water flossing and conventional dental floss on clinical parameters in patients with gingivitis over a one-month period. Method: Thirty healthy, non-smoking adults participated in a four-week clinical study designed as a single-blind, parallel-group trial. The participants were randomly divided into three groups, with each group consisting of 10 individuals. • Group A received a water flosser and a manual toothbrush (WF+MTB). • Group B received dental floss and a manual toothbrush (DF+MTB). • Group C received a manual toothbrush only (MTB). Results: At baseline and 2 weeks, Group B has significantly lower mean plaque index score while at 4 weeks group A has significantly lower plaque index score when compared with other groups. Intra group comparison shows decrease in plaque index scores in Group A(WF+MTB) the difference observed was statistically significant in Group A(WF+MTB). The MSBI values decreased over time for all groups, these changes were not statistically significant. Additionally, there were no statistically significant differences between the groups at any time point. Conclusion: The present study shows that using a water flosser device is easier and more effective than manual flossing for improving gingival health. New products with different mechanism of actions, different delivery methods, or specifications need to be compared. Each product needs to be tested individually and differences between devices should be clinically meaningful. Keywords: Gingivitis, Dental Floss, Water Flosser, Oral Health, Plaque Control |