| CTRI Number |
CTRI/2026/04/107596 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
04/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A simple comparison of three complete teeth set making techniques |
|
Scientific Title of Study
|
Comparative evaluation of clinical performance of conventional vs CAD-CAM milled vs 3D printed complete dentures – a parallel randomised controlled clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rekha Gupta |
| Designation |
Professor SAG and Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
215 , Department of Prosthodontics, Maulana Azad Institute of Dental
Sciences, MAMC Complex, B.S. Zafar Marg
New Delhi
DELHI
110002
India |
| Phone |
9654700952 |
| Fax |
|
| Email |
dr_rekhagupta@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rekha Gupta |
| Designation |
Professor SAG and Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
215 , Department of Prosthodontics, Maulana Azad Institute of Dental
Sciences, MAMC Complex, B.S. Zafar Marg
DELHI
110002
India |
| Phone |
9654700952 |
| Fax |
|
| Email |
dr_rekhagupta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Prince |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
224 , Department of Prosthodontics, MAIDS, MAMC Complex, B.S. Zafar
Marg
New Delhi
DELHI
110002
India |
| Phone |
9711851168 |
| Fax |
|
| Email |
princerr1798@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Institute of Dental Sciences, Maulana Azad Medical College Campus,
Bahadur Shah Zafar Marg,
New Delhi, India-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana azad institute of dental sciences |
| Address |
Department of Prosthodontics, MAIDS, MAMC Complex, B.S. Zafar
Marg, New Delhi, India-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Rekha Gupta |
Maulana Azad Institute of Dental Sciences |
204, Department of Prosthodontics, MAIDS, MAMC Complex, B.S. Zafar
Marg, New Delhi
New Delhi
DELHI |
9654700952
dr_rekhagupta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Institute of Dental Sciences, New Delhi (Govt of NCT of Delhi) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3d-printed dentures |
Patients will be provided dentures fabricated using 3-d printed technique for 1 year |
| Intervention |
CAD-CAM dentures |
Patients will be provided dentures that are fabricated using CAD-CAM technique for 1 year |
| Comparator Agent |
conventional dentures |
Patients will be provided dentures fabricated using traditional techniques for 1 year |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Completely edentulous patients(both arches requiring new complete dentures) with adequate ridge anatomy to support complete denture. Patients must be able and willing to attend follow up visits and able to give informed consent, literate in the language of the OHIP-EDENT used, and with no Contraindications to dental treatment |
|
| ExclusionCriteria |
| Details |
Patients with severe neuromuscular disorders affecting mastication/speech, severely resorbed ridges, xerostomia or condition hampering patient comfort, allergic to dental materials used in fabrication of complete denture or unwilling patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate change in Oral Health Impact Profile for edentulous patients (OHIP-20) in Conventional Complete Dentures, CAD/CAM deenture and 3 d printed dentures |
To evaluate change in Oral Health Impact Profile for edentulous patients (OHIP-20) in Conventional Complete Dentures |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the atient satisfaction among all three group |
At the time of denture delivery & 1 year post delivery of denture |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
15/04/2026 |
| 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="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
|
This randomized controlled clinical trial evaluates the clinical performance and patient reported
outcomes of three types of complete dentures fabricated with different workflows that is
conventional, CAD-CAM Milled, 3D Printed .
Patients will be assigned into three groups receiving different complete dentures, and patient
reported outcomes will be assessed at multiple follow-up intervals using OHIP-20 criteria. |