| 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
|
|
|
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
|
|
|
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
|
|
|
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. |