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CTRI Number  CTRI/2025/08/092725 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparing the chewing efficiency between diabetic and non-diabetic complete denture wearers 
Scientific Title of Study   Comparative evaluation of masticatory performance between diabetic and non-diabetic complete denture wearers – An Observational study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Brunda K 
Designation  Reader 
Affiliation  Dayananda Sagar College of Dental Sciences 
Address  Department of Prosthodontics, 3rd Floor, Dayananda Sagar College of Dental Sciences, S M Hills, K S Layout

Bangalore
KARNATAKA
560111
India 
Phone  9008482766  
Fax    
Email  dr.brundakgowda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Brunda K 
Designation  Reader 
Affiliation  Dayananda Sagar College of Dental Sciences 
Address  Department of Prosthodontics, 3rd Floor, Dayananda Sagar College of Dental Sciences, S M Hills, K S Layout

Bangalore
KARNATAKA
560111
India 
Phone  9008482766  
Fax    
Email  dr.brundakgowda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Brunda K 
Designation  Reader 
Affiliation  Dayananda Sagar College of Dental Sciences 
Address  Department of Prosthodontics, 3rd Floor, Dayananda Sagar College of Dental Sciences, S M Hills, K S Layout

Bangalore
KARNATAKA
560111
India 
Phone  9008482766  
Fax    
Email  dr.brundakgowda@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Brunda K 
Address  Department of Prosthodontics, 3rd Floor, Dayananda Sagar College of Dental Sciences,S M Hills, K S Layout, Bengaluru 560111 
Type of Sponsor  Other [Self sponsored] 
 
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 Brunda K  Dayananda Sagar College of Dental Sciences  3rd Floor, Department of Prosthodontics
Bangalore
KARNATAKA 
9008482766

dr.brundakgowda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dayananda Sagar College of Dental Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Diabetic  
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Completely edentulous diabetic and non-diabetic subjects between the age of 60-80 years.
2. Diabetic since 10years.
3. Denture wearing experience of 1-3 months after the insertion of new dentures with good retention and stability.
 
 
ExclusionCriteria 
Details  1. Subjects with acute and chronic pain related to the somatognathic apparatus.
2. Presence of any lesions of oral mucosa.
3. Problems of neuromuscular nature.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Masticatory efficiency of diabetic and non diabetic Complete denture wearers  3 months after insertion of new complete denture 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   15/09/2025 
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="3"
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  

An individual’s ability to masticate has an important impact on his/her quality of life due to its key role in providing nutrition. According to the studies, masticating ability is closely related to general health as measured by anthropometric factors, especially in senior citizens. It is widely assumed that prolonged diabetes may be associated with diabetic neuropathy and microcirculatory disturbances leading to histopathologic and histochemical changes of the denture bearing mucosa that supports masticatory pressure and pose clinical challenges such as denture adaptation problems and lack of awareness of developing ulcers. Keeping this background in mind, the present study aims to evaluate and compare the masticatory performance between completely edentulous diabetic and non-diabetic patients.

 

 
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