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CTRI Number  CTRI/2026/01/100971 [Registered on: 13/01/2026] Trial Registered Prospectively
Last Modified On: 13/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Effect of different chewing styles on chewing capacity in complete denture patients using a color measuring method. 
Scientific Title of Study   The comparative evaluation of various chewing strokes/cycle on masticatory ability of geriatric population wearing complete denture using photocolorimetry method.  
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krisha Kakadiya  
Designation  Undergraduate student  
Affiliation  K M Shah Dental College and Hospital  
Address  Room no 9 Department of Prosthodontics Crown and Bridges Sumandeep Vidyapeeth Piparia Vadodara Gujarat 391760 India

Vadodara
GUJARAT
391760
India 
Phone  8591118423  
Fax    
Email  krishakakadiya52@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Piyush Javiya 
Designation  Reader 
Affiliation  K M Shah Dental College and Hospital Sumandeep Vidyapeeth 
Address  Room no 9 Department of Prosthodontics Crown and Bridges Sumandeep Vidyapeeth Piparia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  09978998492  
Fax    
Email  drpnjaviya@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Piyush Javiya 
Designation  Reader 
Affiliation  K M Shah Dental College and Hospital Sumandeep Vidyapeeth 
Address  Room no 9 Department of Prosthodontics Crown and Bridges Sumandeep Vidyapeeth Piparia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  09978998492  
Fax    
Email  drpnjaviya@hotmail.com  
 
Source of Monetary or Material Support  
Indian Council for Medical Research (ICMR), V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi-110029 INDIA provided partial monetary support in the said research under STS scheme 
 
Primary Sponsor  
Name  Krisha Kakadiya  
Address  Room no 9 Department of Prosthodontics Crown and Bridges Sumandeep Vidyapeeth Piparia Vadodara Vadodara Gujarat 391760 India 
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 PIYUSH JAVIYA  K M SHAH DENTAL COLLEGE AND HOSPITAL, SUMANDEEP VIDYAPEETH  Room No.09, DEPARTMENT OF PROSTHODONTICS, CROWN & BRIDGE, K M SHAH DENTAL COLLEGE AND HOSPITAL, SUMANDEEP VIDYAPEETH, PIPARIA, VADODARA
Vadodara
GUJARAT 		 09978998492

drpnjaviya@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  THE COMPLETELY EDENTULOUS HEALTHY AND FIRST TIME DENTURE WEARERS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional Complete dentures for included patients  complete dentures shall be given and testing for chewing efficiency shall be evaluated for total of maximum of 30 minutes per patient  
Comparator Agent  NOT APPLICABLE  this is single arm study hence do not require comparison 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  systematically health patients who are getting complete dentures for first time 
 
ExclusionCriteria 
Details  1. participants with immuno compromised states
2. participants with poor retention and stability of dentures
3. participants with temporomandibular disorders
4. participants not willing to chew beetroots 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
masticatory ability of geriatric population using photocolorimetry   1 week after dentures are given to the patients 
 
Secondary Outcome  
Outcome  TimePoints 
patients perception about retention of new complete dentures   1 week after denture are given to the patients just before checking masticatory ability  
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   02/02/2026 
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="1"
Months="0"
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  

Introduction

Edentulism is common in the geriatric population due to increased life expectancy. Tooth loss impairs mastication, leading to poor digestion and compromised nutrition. Although implant-based dentures exist, conventional complete dentures remain the more feasible option in developing countries due to affordability.

Masticatory ability in denture wearers depends on denture fit, oral mucosal health, ridge form, and the occlusal scheme. Chewing pattern also influences chewing efficiency. This study focuses on assessing the effect of switching chewing sides within a mastication cycle.

 

Need for the Study

 There is no previous research evaluating how different chewing strokes/cycle side-switch patterns affect chewing efficiency in complete denture wearers using the photocolorimetry method. Hence, this study aims to fill this gap.

 

Objectives

Primary Objectives

 

  1. 1.    Evaluate masticatory ability at different chewing stroke side-switch points.

 

  1. 2.       Evaluate masticatory ability during unilateral chewing.

 

  1. 3.       Evaluate masticatory ability during freestyle chewing.

 

  1. 4.       Compare side-switch techniques with unilateral and freestyle chewing using photocolorimetry.

 

Secondary Objective

Assess patient perception of denture retention using Visual Analog Scale (VAS).

 

Methodology

Study includes completely edentulous geriatric patients from Prosthodontics department.

Complete dentures fabricated as per standard protocols; a 1-week settling period is allowed.


Masticatory ability test:

Patients chew a pre-weighed beetroot piece for 20 strokes.

Different groups: side-switch strokes  unilateral chewing, freestyle chewing.

Beetroot dye mixed with saliva is collected.

10 ml distilled water added; mixture centrifuged for 2 minutes.

Solution filtered and analyzed using photocolorimetry.

A standard beetroot solution prepared similarly for comparison.

Chewing efficiency measured by comparing sample absorbance with standard.

 

Patients rate denture retention on VAS.

 

Data compilation followed by appropriate statistical analysis.

 

Conclusion

The study aims to identify which chewing pattern provides maximum masticatory efficiency in complete denture wearers, potentially guiding clinical recommendations for geriatric patients.

 
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