| CTRI Number |
CTRI/2026/02/105053 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
21/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Study to Compare Denture fit and efficiency Between Traditional and Digital Denture designed using open-source software |
|
Scientific Title of Study
|
Crossover trial of complete dentures fabricated with conventional technique versus digital workflow using an open access software: Evaluation of fit, masticatory force and patient satisfaction. |
| 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 Shefali Singla |
| Designation |
Head of department |
| Affiliation |
Dr harvansh singh judge institute of dental sciences and hospital |
| Address |
Department of prosthodontics, Dr harvansh Singh judge institute of dental sciences and hospital, sector 25, Panjab university
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9417194185 |
| Fax |
|
| Email |
shefali_singla@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalit Kumar |
| Designation |
Associate Professor |
| Affiliation |
Dr.harvansh singh judge institute of dental sciences and hospital |
| Address |
Department of prosthodontics, Dr.harvansh Singh judge institute of dental sciences and hospital, sector 25, Panjab university
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9914419876 |
| Fax |
|
| Email |
drlalitbida@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Sahore |
| Designation |
Assistant Professor |
| Affiliation |
Dr.harvansh singh judge institute of dental sciences and hospital |
| Address |
Department of prosthodontics, Dr.harvansh Singh judge institute of dental sciences and hospital, sector 25, Panjab university
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9878021345 |
| Fax |
|
| Email |
dr_puneetsharma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr. harvansh singh judge institute of dental sciences and hospital,Panjab university, sector 25, chandigarh ,INDIA , 160014 |
|
|
Primary Sponsor
|
| Name |
Dr harvansh singh judge institute of dental sciences and hospital |
| Address |
Dr. harvansh singh judge institute of dental sciences and hospital,Panjab university, sector 25 , chandigarh ,INDIA , 160014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shefali Singla |
Dr Harvansh Singh Judge Institute of Dental Sciences, Panjab University, sector 25 , Chandigarh |
room no. 126, Department of Prosthodontics,Dr Harvansh Singh Judge Institute of Dental
Sciences Panjab University Chandigarh
Chandigarh
CHANDIGARH |
9417194185
shefali_singla@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committe , Panjab university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
analogue conventional denture workflow |
Preliminary impressions will be made with an irreversible hydrocolloid impression material.
At the second visit, definitive impressions will be made using Zinc oxide Eugenol Impression paste after functional border molding with green stick a modeling plastic impression compound (Peri Compound; GC Corp) and a polysulfide impression material (Permlastic; Kerr Corp). For the fabrication of conventional CDs, the record base was fabricated with an autopolymerizing polymethyl methacrylate resin.
At the third visit, the interarch relationship was recorded by using the record base and wax occlusal rim assembly with an occlusal relationship registration material (Aluwax; Aluwax Dental Products Co) for both groups, and appropriate artificial teeth were selected The artificial teeth will be arranged in the conventional manner for the fabrication of conventional CDs and then process it and insert it. Conventional CDs were fabricated by using a standard injection molding technique. for 1 month |
| Intervention |
digital denture workflow |
Based on intraoral scan of maxillary and mandibular arches, a custom tray integrated with occlusal rims and maxillary anterior teeth will be fabricated based on anatomic position indicators for anterior teeth and plane. This will facilitate recording of final impressions after functional border molding of trays, evaluation of lip support and position of the anterior incisors and physical recording of jaw relation in single visit.Presence of six anterior teeth at occlusal plane level will act as tray handle and also facilitate accurate recording of centric relation. These impressions and interocclusion record will be digitalized for further virtual teeth arrangement and 3d printing of complete denture. This work flow blends conventional principles of impression and jaw relation and anterior tryin with digital denture designing and processing using a free open access software with no additional armamentarium and number of clinical steps reduced to 3 . for 1 month |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 30 y
Patients with complete edentulism or those who will transition to fully edentulous state after extraction of all residual teeth
Patients who voluntarily agreed to participate in this study and provided their written informed consent prior to undergoing any study-related procedures
|
|
| ExclusionCriteria |
| Details |
Patients who could not read informed consent form
Patients experiencing problems with mouth opening and closing because of temporomandibular disorders
Patients with congenital or acquired defects in maxilla and/or mandible
Patients judged ineligible for study inclusion by principal investigator or designated contact person because of clinically significant medical or mental health finding
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| internal adaptation of intervention and comparator group of complete denture |
at time of insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evaluate Masticatory force with each group of complete denture |
at time of intervention |
| patient satisfaction |
after 1 month |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
15/03/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study aims to propose to devise and evaluate a hybrid
analogue-digital mode using open access software. Based on intraoral scan of
maxillary and mandibular arches, we will design a custom tray integrated with
occlusal rims and maxillary anterior teeth based on anatomic position
indicators for anterior teeth and plane. At second clinical appointment final
impression with conventional protocol will be made followed by jaw relation and
verification of anterior teeth position(anterior tryin). Lip support and position of the anterior
incisors can be evaluated at this stage which will minimize esthetic complaints These impressions and
interocclusion record will be digitalized for further virtual teeth arrangement
and 3d printing of complete denture. This work flow blends conventional
principles of impression and jaw relation and anterior tryin with digital denture
designing and processing using a free openaccess software with no additional
armamentarium and number of clinical steps reduced to three. No system specific
software , proccessors or armamentarium will be
required for designing these dentures. Scanning designing and printing
of custom tray with teeth can be completed within an hour, allowing for
same-day records without additional patient visits . Clinician can choose to
shift to conventional mode after jawrelation appointment in case of financial
issue or unavailability of digital setup in remote areas. |