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CTRI Number  CTRI/2024/07/071503 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 04/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Assessment of efficacy of water flosser and regular floss for removal of food particles in patients with Crowns and Bridges Randomised Control Trial  
Scientific Title of Study   Evaluation of efficacy of water flosser and regular floss for plaque removal in patients with Fixed Dental Prosthesis A Randomised Control 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  Khushi Sethia 
Designation  Intern 
Affiliation  Manipal College of Dental Sciences Mangalore, Affiliated to Manipal Academy of Higher Education 
Address  Kasturba Medical College, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka 575001 Department of Prosthodontics Crown and Bridge, Ground floor department number 5.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9619493883  
Fax    
Email  sethia.mukesh@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Vignesh Kamath 
Designation  Assistant Professor 
Affiliation  Manipal College of Dental Sciences Mangalore, Affiliated to Manipal Academy of Higher Education 
Address  Kasturba Medical College, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka 575001, Department of Prosthodontics Crown and Bridge, Ground floor department number 5.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9036979107  
Fax    
Email  vignesh.kamath@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vignesh Kamath 
Designation  Assistant Professor 
Affiliation  Manipal College of Dental Sciences Mangalore, Affiliated to Manipal Academy of Higher Education 
Address  Kasturba Medical College, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka 575001, Department of Prosthodontics Crown and Bridge, Ground floor department number 5.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9036979107  
Fax    
Email  vignesh.kamath@manipal.edu  
 
Source of Monetary or Material Support  
Oracura Solutions Pvt. Ltd. 6th Floor, Unit 1, Plot No 233/2 Vidhani Kalpavruksha, MIDC Industrial Area, T.T.C. Industrial Area, Mumbai - Pune Hwy, Shiravane, Nerul, Navi Mumbai, Maharashtra 400706 
 
Primary Sponsor  
Name  Khushi Sethia 
Address  Kasturba Medical College, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka 575001, Department of Prosthodontics Crown and Bridge, Ground floor department number 5. 
Type of Sponsor  Other [self] 
 
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 
Khushi Sethia  Manipal College of Dental Sciences, Mangalore  Kasturba Medical College, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka 575001, Department of Prosthodontics Crown and Bridge, Ground floor department number 5.
Dakshina Kannada
KARNATAKA 		 9619493883

sethia.mukesh@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MCODS, Mangalore, Affiliated to Manipal Academy of Higher Education  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All individual are healthy human volunteers on which we will be assessing plaque scores using Silness and Loe Plaque index  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Manual toothbrush   1 month, twice daily 
Comparator Agent  Regular floss  1 month, twice daily 
Intervention  Waterflosser  1 month, twice daily 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with Fixed Dental Prosthesis Posterior
Patients with Single crown and implant Posterior
Patient with Implant supported prosthesis.
Patient with more than one form of fixed dental prosthesis in the oral cavity
Patient with the chief complaint of food lodgment.
Type 1 and type 2 embrasures
 
 
ExclusionCriteria 
Details  Patients with tooth mobility
Patients with periodontal disease
Patients with extensive Inter Dental Bone loss.
Patients with Peri Implantitis
Patients on any antibiotic medication or any allergies
Crowns with improper contact
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Silness and Loe Plaque Index  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
maintenance of oral hygiene  4 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/08/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

ABSTRACT

 

TITLE: Evaluation of efficacy of water flosser and regular floss for plaque removal in patients with fixed dental prosthesis: a randomised control study 

 

 The rise in fixed dental prostheses (FDPs) usage necessitates one to maintain good oral hygiene to prevent complications such as decay, gingivitis, periodontitis, Peri Implantitis and bone loss. The inaccessible areas like the interdental spaces, challenge traditional cleaning methods, impacting FDP longevity. This study explores the efficacy of different interdental aids in removal of plaque in patients with fixed dental prosthesis.

 

AIMS & OBJECTIVES:

Evaluate various interdental cleaning aids for FDP patients.

Enhance patient oral hygiene to prolong prosthesis lifespan.

Educate the patient on how to take care of the prosthesis and teaching them the correct way to brush their teeth, use water flosser and regular floss

Motivate patients for sustained good oral hygiene practices.

 

MATERIALS AND METHODS:

DESIGN:

The study will be using a Parallel trail design in which we concurrently randomise patients into one of the three treatment groups; A,B,C. Patients will be selected according to eligibility criteria. After which Plaque scores will be measured using Silness & Loe Plaque Index over one month with 2 recall visits; at 1 week and 3 week respectively. The index will be measured by two calibrated investigators who will be blinded to each other’s results.

The 3 groups will be Group A(Participants using manual toothbrush as a plaque removal aid),Group B(participants using  regular floss for the plaque removal aid),Group C (Participants using  water flosser for the plaque removal aid). A total sample size will be of 30 with 10 in each group.

 

CONCLUSION:

In conclusion the motive of the study is to help patients maintain a good oral hygiene and increase the longevity of the prosthesis so they can have a comfortable dental experience. At the same time educate the patient on how to take care of the prosthesis and teaching them the correct way to brush their teeth and use water flosser and floss, hence motivate them to maintain good hygiene.

 

 

 
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