| CTRI Number |
CTRI/2025/05/087550 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessing Plaque Removal Efficiency: Water Jet vs. Regular Floss in Adults |
|
Scientific Title of Study
|
Efficacy of regular floss vs water jet after a single use in plaque reduction among adults- A Randomized clinical 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 |
Banda Sri Deepti Sindhusha |
| Designation |
Post graduate |
| Affiliation |
|
| Address |
Sibar institute of dental sciences, Takkellapdu, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9676307893 |
| Fax |
|
| Email |
sindhusha61297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R Srinivas |
| Designation |
Professor |
| Affiliation |
|
| Address |
Sibar institute of dental sciences, Takkellapadu, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9490379721 |
| Fax |
|
| Email |
srnvs.ravuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P Srinivas |
| Designation |
HOD&Professor |
| Affiliation |
|
| Address |
Sibar institute of dental sciences, Takkellapadu, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9849368466 |
| Fax |
|
| Email |
srinivaspachava@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences, Takellapadu, Guntur, Andhra Pradesh- 522509 |
|
|
Primary Sponsor
|
| Name |
Sibar institute of dental sciences |
| Address |
Sibar institute of dental sciences, Takellapadu, Guntur, Andhra Pradesh |
| Type of Sponsor |
Other [Private dental 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 |
| Banda Sri Deepti Sindhusha |
Sibar institute of dental sciences |
Sibar institute of dental sciences, Department of public health dentistry, room.no 10, Takkellapadu, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH |
9676307893
sindhusha61297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with low plaque score |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Regular floss |
plaque scores at baseline and immediately after post intervention |
| Intervention |
water flosser |
plaque score at baseline and immediately after post intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects aged 18–45 years
2.people with fair to poor oral hygiene.
3.People especially who have lower canines and premolars with no rotations or crowding.
4.Pocket depth less than 3
5.Subjects didn’t use any floss type for the last 24 hours and who gave informed consent.
6.Subjects with no known medical history.
|
|
| ExclusionCriteria |
| Details |
1.Presence of aggressive periodontitis and presence of severe periodontitis, that is, clinical attachment loss of greater than or equal to 5 mm.
2.Subjects with any physical limitations that might compromise the normal flossing technique.
3.Evidence of neglected oral hygiene or major hard or soft tissue lesions or trauma, gross caries or the other hard tissue pathology, heavy calculus, orthodontics, prosthodontics, and oral piercings, a medical condition with a requirement of prophylactic antibiotic coverage before dental treatment.
4.Use of antibiotic therapy or anti-inflammatory medications in the previous 28 days.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of regular floss and water floss in reduction of plaque scores. |
baseline and immediately after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To know the reduction in plaque score when regular floss is used before & immediately after intervention.
2. To know the reduction in plaque score when water floss is used before & immediately after intervention. |
baseline & immediately after intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/06/2025 |
| 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="2"
Days="0" |
|
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
|
A randomized controlled clinical trial was conducted to compare the plaque removal efficacy of water flosser and regular floss. It is a Single blind study with split mouth technique.The study will be explained to the study participants and informed consent will be obtained. Subjects will be selected according to inclusion and exclusion criteria and Rustogi et al modified navy plaque index (RMNPI) will be used to measure plaque index using WHO probe for all the subjects prior to the intervention by an examiner. The type of floss used will be randomly assigned to each side of the oral cavity; unflavored waxed regular floss will be used in one side, while a water flosser will be used in the other side. Regular floss was coded as ‘1’ and water flosser was coded as ‘2’. For each subject a coded chit was picked and assigned to right side and the other floss was assigned to left side. Standardized oral hygiene instructions and use of the regular floss & water flosser will be demonstrated to all subjects. Under supervision of a trained investigator subjects will be asked to use unflavored waxed regular floss & water flosser as assigned and post intervention plaque scores were again obtained. |