| 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
|
|
|
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
|
|
|
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. |