| CTRI Number |
CTRI/2025/11/097618 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different types of floss in improving oral health |
|
Scientific Title of Study
|
Regular floss and Water flosser in improving gingival health - 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 |
Anjali Jain |
| Designation |
Postgraduate Student |
| Affiliation |
Department of Public health dentistry g4 b block Peoples college of dental sciences, bhanpur, Bhopal |
| Address |
Department of public health dentistry Room no. G4 B block Peoples college of dental sciences, bhanpur, Bhopal
Peoples college of dental sciences, bhanpur, Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07987277550 |
| Fax |
|
| Email |
dentalmitra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahana S |
| Designation |
Professor and head of the department public health dentistry |
| Affiliation |
Peoples college of dental sciences, bhanpur, Bhopal |
| Address |
Department of public health dentistry Room no. G4 B block Peoples college of dental sciences, bhanpur, Bhopal
Department of public health dentistry Room no. G4 B block Peoples college of dental sciences, bhanpur, Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9235650627 |
| Fax |
|
| Email |
sahana20579@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Jain |
| Designation |
Student |
| Affiliation |
Peoples college of dental sciences, bhanpur, Bhopal |
| Address |
Department of public health dentistry Room no. G4 B block Peoples college of dental sciences, bhanpur, Bhopal
Department of public health dentistry Room no. G4 B block Peoples college of dental sciences, bhanpur, Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07987277550 |
| Fax |
|
| Email |
dentalmitra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anjali Jain |
| Address |
Peoples college of dental sciences and research center bhanpur bhopal 462037 |
| Type of Sponsor |
Other [self] |
|
|
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 Anjali Jain |
Peoples college of dental sciences and reserch center |
Department of public health dentistry Room no. G4 B block Peoples college of dental sciences bhanpur bhopal
Bhopal
MADHYA PRADESH |
07987277550
dentalmitra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PCDS AND RC |
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 |
| Comparator Agent |
dental floss |
Group 1 was assigned to dental floss which was used on left mandibular quadrants. Participants were given verbal instructions and demonstration of the ADA recommended flossing technique (Cut the floss from the container to around 18 inches. Then encircle your left middle finger with one end of the floss and your right middle finger with the other end. After this Using your thumbs and forefingers, carefully press the floss into place. Make a C shape with the floss as you slide it between your teeth and up against the tooths side.
To brush the side of the tooth, pull the floss up and down. Be careful not to jerk; instead, use steady, soft strokes. Proceed with the procedure until all of your teeth, including front and back, are covered and rinse with water after the procedure ends). The participants used a waxed string floss for 30 seconds on assigned portion of the mandible. The participants were refrained from use of any form of mouth wash after the procedure. |
| Intervention |
Water flosser |
Group 2 was assigned to water flosser which was used on right mandibular quadrants. Patients were given verbal instructions and demonstration of the usage technique (Initially pour lukewarm water into the reservoir. Lock the tip in position after selecting the regular tip. Start with your back teeth and put the tip in your mouth. Make sure to spray every inter-dental space while holding the tip away from your teeth and gums to avoid direct contact. Set the water pressure to medium and turn on your water flosser. Following this pay attention to your gum line. To make sure you obtain all of the food and tartar remnants, go tooth by tooth. Target the tooths crown, the gum line, and the distance between each teeth. For approximately two seconds, hold the water over each tooth. Both the interior and the outside of your teeth should undergo this procedure.). The participants used the water flosser for 30 seconds on assigned portion of the mandible. The participants were refrained from use of any form of mouth wash after the procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who were in the age range of 18-45 who reported to the out patient department of peoples college of dental sciences and research center who consented to be part of the study.
2. Participants who have minimum of 20 scoreable teeth, excluding third molars with pocket depth less than or equal to 3mm with fair to poor oral hygiene who abstained from using any inter-dental aid for 24 hours before the study were included.
|
|
| ExclusionCriteria |
| Details |
1. Participants who had implants, orthodontic appliances, bridges, crown or any other appliances.
2. Participants with any systemic conditions.
3. Participants on hormone therapy or steroids.
4. Participants who were absent on the day of the study.
5. Participants who did not consent to the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of water flosser in improving gingival health.
To assess the efficacy of regular floss in improving gingival health. |
After the intervention, plaque and gingival index scores were recorded after 24 hours, 48 hours and 72 hours respectively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
30/11/2025 |
| 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
|
Periodontal disease and dental caries are the two most prevalent oral illnesses linked to plaque Today, brushing is still the most popular self performed mechanical technique for removing and controlling plaque biofilm at home The best way to remove interdental plaque is with interdental aids The choice of interdental aids is influenced by the types of embrasures the abilities of medical specialists and the desire to employ them The gold standard for eliminating interdental plaque is dental floss The American Dental Association states that up to 80 percent of intedental plaque can be eliminated with dental floss But about 10 percent to 30 percent of adults routinely floss, according to research. Numerous designs of interdental devices are on the market to get around this limitation The water flosser is a reasonably simple interdental tool that has recently been developed for everyday usage at home Since there are limited number of studies on the comparative effectiveness of water flosser and dental floss in different populations this study aims to assess the efficacy of water flosser when compared to regular floss in improving gingival health Before the commencement of the study informed consent will be obtained from all the participants The study had previously been approved by the institutional ethics committee Participants confidentiality will be maintained throughout the study and they were informed about the investigation in advance For each participant the split mouth technique is used which divides the mouth into left and right mandibular halves Group 1 will be assigned to dental floss which will be used on left mandibular quadrant. Group 2 will be assigned to water flosser which will be used on right mandibular quadrant This standardized assignment of groups willl be done to reduce confusion and enhance the clarity of participants during self administration The study outcome will be assessed using the plaque and gingival index by comparing the baseline scores to the sores obtained after 24 hours 48 hours and 72 hours respectively |