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CTRI Number  CTRI/2020/01/023007 [Registered on: 27/01/2020] Trial Registered Retrospectively
Last Modified On: 24/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of patient satisfaction and masticatory efficiency in complete dentures. 
Scientific Title of Study   COMPARISON OF PATIENT SATISFACTION AND MASTICATORY EFFICIENCY IN COMPLETE DENTURES FABRICATED BY CONVENTIONAL METHOD AND BIOFUNCTIONAL PROSTHETIC SYSTEM (BPS) - A RANDOMIZED CLINICAL TRIAL. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VIVEK SHANKAR P 
Designation  PG STUDENT 
Affiliation  SRM DENTAL COLLEGE AND HOSPITAL, RAMAPURAM. 
Address  DEPARTMENT OF PROSTHODONTICS, PG SECTION,THIRD FLOOR,SRM DENTAL COLLEGE AND HOSPITAL, BHARATHI SALAI,RAMAPURAM, CHENNAI

Chennai
TAMIL NADU
600089
India 
Phone  9094364641  
Fax    
Email  drvivekshankarmds@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  JAGDISH SK 
Designation  READER, DEPARTMENT OF PROSTHODONTICS 
Affiliation  SRM DENTAL COLLEGE AND HOSPITAL, RAMAPURAM. 
Address  DEPARTMENT OF PROSTHODONTICS, THIRD FLOOR, SRM DENTAL COLLEGE AND HOSPITAL, BHARATHI SALAI, RAMAPURAM, CHENNAI

Chennai
TAMIL NADU
600089
India 
Phone  9940163850  
Fax    
Email  jagdishsk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PETER JOHN 
Designation  READER, DEPARTMENT OF PROSTHODONTICS 
Affiliation  SRM DENTAL COLLEGE AND HOSPITAL, RAMAPURAM. 
Address  DEPARTMENT OF PROSTHODONTICS, THIRD FLOOR, SRM DENTL COLLEGE AND HOSPITAL, BHARATHI SALAI, RAMAPURAM, CHENNAI

Chennai
TAMIL NADU
600089
India 
Phone  9884444689  
Fax    
Email  drpeterjohn@gmail.com  
 
Source of Monetary or Material Support  
VIVEK SHANKAR P, PG STUDENT, DEPARTMENT OF PROSTHODONTICS, PG SECTION, THIRD FLOOR, SRM DENTAL COLLEGE AND HOSPITAL, BHARATHI SALAI, RAMAPURAM, CHENNAI - 600089  
 
Primary Sponsor  
Name  VIVEK SHANKAR P 
Address  DEPARTMENT OF PROSTHODONTICS, THIRD FLOOR, SRM DENTAL COLLEGE AND HOSPITAL, BHARATHI SALAI, RAMAPURAM, CHENNAI 
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 
Dr Vivek Shankar P  SRM DENTAL COLLEGE AND HOSPITAL, RAMAPURAM  Department of Prosthodontics, Third Floor, PG Section, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089
Thiruvallur
TAMIL NADU 
9094364641

drvivekshankarmds@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, SRM Dental College, Ramapuram, Chennai.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  First time denture wearers,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Complete dentures fabricated by Biofunctional Prosthetic System (BPS).  Biofunctional prosthetic system is a newer method of fabricationg complete denture. 
Comparator Agent  Complete dentures fabricated by conventional method.  The regular method of fabricating complete denture. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Healthy adult patient requiring a new set of complete dentures
2. Patients who are self motivated to wear dentures
3. Patients who are unaware of the different types and methods of fabrication of complete dentures / First time denture wearers.
4. Well formed residual alveolar ridges.
 
 
ExclusionCriteria 
Details  1. Patients wearing complete dentures who are unsatisfied despite no obvious defects in the existing denture.
2. Debilitating systemic diseases.
3. TMJ disorders.
4. Diseases of bones and joints.
5. Oral mucosal diseases.
6. Neurological diseases.
7. Psychiatric /Cognitive disorders.
8. Pathological changes in residual ridges.
9. Knife edge ridges.
10. Soft tissue abnormalities/Flabby ridges.
11. Thin mucosa/poor keratinisation.
12. Presence of tori/hard tissue undercuts.
13. Smoking, pan chewing.
14. Parafunctional habits.
15. Xerostomia/Hypersalivation.
16. Restricted tongue movement.
17. Palatal defects. (Soft palate/Hard palate)
18. Hyperactive mentalis muscle.
19. Very high frenal attachments. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Patient satisfaction
Masticatory efficiency 
1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Frequency of denture adjustments  1 week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/01/2018 
Date of Study Completion (India) 30/11/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Write up in process 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Clinical procedures:

Complete dentures, both conventional and BPS, for the patients in test and control groups will be done by a single operator. The operator will be postgraduate student and will be supervised by an experienced clinical instructor. Dentures in control group will be fabricated using conventional clinical procedures and those in the test group will be fabricated using the BPS protocol. Both the dentures will use the same teeth set (Ivoclair). Both the dentures will be processed using the same resin (Ivoclair) by injection moulding technique. No logo will be used on dentures fabricated using BPS protocol.

 

Data collection and analysis:

All patients will be evaluated by a single evaluator, who will send the data to the data collector/analyser. The data collector/analyser will be involved in grouping the data and statistical evaluation.

 

Outcomes and outcome assessment:           

            The primary outcomes will be patient satisfaction and masticatory efficiency. These data will be collected 6 weeks after the denture insertion appointment. Patient satisfaction will be evaluated by using  Oral Health‑Related Quality of Life questionnaire, specifically designed for edentulous patients (Oral Health Impact Profile for edentulous subjects) [OHIP‑EDENT]. Masticatory efficiency will be evaluated using wet sieve method of analysis. Secondary outcome will be frequency of denture adjustments required after denture insertion appointment and denture repair. Each patient will be followed up for a period of 6 months.

 

Evaluation of primary outcome which is patient satisfaction and masticatory efficiency is to be done at the time of 6 weeks post insertion because the previous studies suggest it to be optimal for review.

 

 
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