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CTRI Number  CTRI/2025/07/091823 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 26/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of traditional Floss Over Unifloss in the Treatment of Gum Health 
Scientific Title of Study   Efficiency and Patient Compliance of Conventional Floss Over Unifloss in the Management of Gingival Health 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rupali Singh 
Designation  Student 
Affiliation  GITAM Dental College 
Address  Department of Periodontics, Room no:6, Dental college building

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  9391412447  
Fax    
Email  singhrup4514@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jerusha P 
Designation  Assistant Professor 
Affiliation  GITAM Dental College 
Address  Department of Periodontics, Room no:6, Dental College Building

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  9177508338  
Fax    
Email  jerushap31@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jerusha P 
Designation  Assistant Professor 
Affiliation  GITAM Dental College 
Address  Department of Periodontics, Room no:6, Dental College Building

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  9177508338  
Fax    
Email  jerushap31@gmail.com  
 
Source of Monetary or Material Support  
Dr.N.T.R University of Health Sciences 
 
Primary Sponsor  
Name  Dr.N.T.R University of Health Sciences 
Address  Beside New Government General Hospital, Ramavarappadu, Vijayawada - 520008, Andhra Pradesh, India 
Type of Sponsor  Other [Affiliated University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jerusha P  GITAM Dental College  Room 6, 1st Floor, Department of Periodontics
Visakhapatnam
ANDHRA PRADESH 		 9177508338

jerushap31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GITAM DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Floss  Levels of plaque to be scored using plaque index at baseline and at 2 weeks and gingival inflammation will be assessed using gingival bleeding index at baseline and at 2 weeks. Gingival trauma will be assessed using Carter-Hanson scoring index at 2 weeks. Patient compliance will be assessed using post trial questionnaire. 
Intervention  Unifloss  Levels of plaque to be scored using plaque index at baseline and at 2 weeks and gingival inflammation will be assessed using gingival bleeding index at baseline and at 2 weeks. Gingival trauma will be assessed using Carter-Hanson scoring index at 2 weeks. Patient compliance will be assessed using post trial questionnaire. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Individuals with OHI-S score good will be considered for the study, Type I embrasures, No missing teeth except for third molars, Participants who have not used floss for interdental cleaning along with tooth brushing, Individuals who have not undergone professional oral prophylaxis in the last two months, Overall good general health, Individuals who are willing to participate and are available for the 2 weeks duration of the study 
 
ExclusionCriteria 
Details  Individuals with chronic or systemic illnesses, Malaligned teeth – crowding, Pregnant women and lactating mothers, Smokers, Subjects who received oral prophylaxis in the duration of last two months prior to the study, History of extensive subgingival restorations or overhanging restorations, crowns or partial dentures. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
levels of plaque are calculated using plaque index  Baseline and 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival inflammation will be assessed using gingival bleeding index  Baseline and 2 weeks 
Gingival Trauma will be assessed using Carter Hanson scoring  At 2 weeks 
Patient compliance using post trial questionnaire  At 2 weeks 
 
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   N/A 
Date of First Enrollment (India)   11/08/2025 
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 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   Dental plaque is a structured biofilm harboring complex microbial communities and serves as a primary etiological factor in the progression of gingival and periodontal diseases.  Throughout history, innumerous devices and methodologies bearing different levels of efficacy have been introduced over the counter for promoting gingival health. Substantial clinical evidence shows the importance of mechanical debridement through daily tooth brushing in disrupting the plaque biofilm. However, it has been reported that tooth brushing alone is inadequate for effective plaque removal in the interdental embrasure spaces and hence the need for other adjunctive aids such as dental floss is emphasized. Over the years, the usage of dental floss as an adjunctive interdental aid has not been very successful due to its technique sensitivity, time consumption as well as lack of patient motivation and cooperation.
The purpose of the study is to assess the effect of dental floss as an adjunctive interdental aid in promoting gingival health and to compare the effect of conventional flossing technique versus floss with holder on patient compliance.

The above study may be helpful to add to the existing evidence that floss is an important adjunctive interdental aid to reduce the accumulation of plaque biofilm and gingival inflammation and thus promote gingival health.

 
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