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CTRI Number  CTRI/2025/06/088699 [Registered on: 12/06/2025] Trial Registered Prospectively
Last Modified On: 12/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to compare dentures made using digital dentures and traditional methods in dental college patients: Evaluating the ease of fabrication, comfort and fit.  
Scientific Title of Study   Digital versus conventional complete removable dental prostheses fabrications in a predoctoral settings- An In vivo study 
Trial Acronym  Not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Smitha Sharan 
Designation  Professor 
Affiliation  Dayananda Sagar College of Dental Sciences 
Address  Department of Prosthodontics, 3rd Floor, Dayananda Sagar College of Dental Sciences, SM Hills, KS Layout, Bangalore

Bangalore
KARNATAKA
560111
India 
Phone  9449087923  
Fax    
Email  smithasharan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smitha Sharan 
Designation  Professor 
Affiliation  Dayananda Sagar College of Dental Sciences 
Address  Department of Prosthodontics, 3rd Floor, Dayananda Sagar College of Dental Sciences, SM Hills, KS Layout, Bangalore

Bangalore
KARNATAKA
560111
India 
Phone  9449087923  
Fax    
Email  smithasharan@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, SM Hills, KS Layout, Bangalore

Bangalore
KARNATAKA
560111
India 
Phone  9008482766  
Fax    
Email  dr.brundakgowda@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences, 4th T Block, Jayanagar, Bangalore 560041 
 
Primary Sponsor  
Name  Rajiv Gandhi University of Health Sciences 
Address  4th T Block Jayanagar Bangalore 560041 
Type of Sponsor  Other [University of Health Sciences] 
 
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 Smitha Sharan  Dayananda Sagar College of Dental Sciences  3rd Floor, Department of Prosthodontics
Bangalore
KARNATAKA 
9449087923

smithasharan@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  Completely edentulous upper and lower arches 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Complete Dentures  Clinical treatment outcome, patients satisfaction, dental students preferences 
Intervention  Digital Complete Dentures  Clinical treatment outcome, patient satisfaction, dental students preference 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Maxillary and mandibular edentulous jaws for more than 3 months
Acceptance of removable complete denture restoration
Good cooperative attitude  
 
ExclusionCriteria 
Details  Obvious defect in the maxillary and mandibular jaws
Serious oral mucosal diseases without effective treatment
Obvious flabby alveolar ridge 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical treatment outcomes, patient satisfaction and dental student preferences  1 month after the denture insertion 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   03/09/2025 
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="1"
Months="6"
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  

Informed consent from 15 completely edentulous patients (Average 55-60 years of age) will be taken before participating in the study. Two sets of maxillary and mandibular complete removable dental prosthesis will be fabricated for each subject by fourth-year predoctoral dental students.

The 15 students participating in the study will receive instructions and training on the fabrication of digital and conventional complete removable dental prosthesis as part of their didactic preclinical curriculum.

Each subject receives 1 digital and 1 conventional set (Maxillary and mandibular) of complete removable dental prosthesis. The digital complete removable dental prosthesis will be fabricated as following, primary impression will be scanned as per the 3Shapes protocol for scanning completely edentulous arches, definitive impressions will be made using closed mouth technique. Records and completed laboratory work authorization forms will be sent to Precise dental art laboratory. A class I occlusal relationship will be requested for all complete removable dental prosthesis. Laboratory personnel at Precise Dental Art will scan the records using 3shape Trios 3 and submit a virtual tooth arrangement for preview and approval before fabricating the dentures. Once the digital dentures are ready, they will be printed for try in. Post try-in, definitive prosthesis will be printed as a split file, printed, and finished. The conventional set of complete removable dental prosthesis will be fabricated with the 5-appointment process. Post- insertion corrections will be done, following which the patient will wear the denture for a period of one month.

All the students in the predoctoral setting will be supervised and guided by faculty. Two separate satisfaction questionnaires in the form of 5-point Likert rating scale from 0 to 4 will be used by faculty, pre-doctoral students and patients to evaluate and grade the dentures.

The findings are expected to provide evidence-based recommendations for improving denture quality, enhancing dental education, and streamlining prosthodontic services. This research holds potential to influence curriculum development, clinical practice standards, and the broader integration of digital dentistry in healthcare institutions. 
 
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