| CTRI Number |
CTRI/2026/01/100408 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing patient comfort and satisfaction with two types of complete dentures in people without teeth: A randomized crossover clinical trial |
|
Scientific Title of Study
|
Assessment of long-term patient satisfaction of complete dentures fabricated using simplified and conventional complete dentures on oral health impact profile for edentulous patients (OHIP-EDENT): A randomized double-blinded crossover 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 |
Divakar S |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Dental College and Hospital |
| Address |
ESIC Dental College and Hospital, ESIC Medical Campus, Kalaburagi
Gulbarga
KARNATAKA
585106
India |
| Phone |
7418296274 |
| Fax |
|
| Email |
divakarsanthanam17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divakar S |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Dental College and Hospital |
| Address |
ESIC Dental College and Hospital, ESIC Medical Campus, Kalaburagi
KARNATAKA
585106
India |
| Phone |
7418296274 |
| Fax |
|
| Email |
divakarsanthanam17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divakar S |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Dental College and Hospital |
| Address |
ESIC Dental College and Hospital, ESIC Medical Campus, Kalaburagi
KARNATAKA
585106
India |
| Phone |
7418296274 |
| Fax |
|
| Email |
divakarsanthanam17@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Dental College and Hospital, ESIC Medical Campus, Kalaburagi, Karnataka, India - 585106 |
|
|
Primary Sponsor
|
| Name |
Department of Prosthodontics ESIC Dental College and Hospital |
| Address |
ESIC Dental College and Hospital, ESIC Medical Campus, Kalaburagi, Karnataka, India - 585106 |
| 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 |
| Dr Divakar S |
ESIC Dental College and Hospital |
Room No. 3, Department of Prosthodontics ESIC Dental College and Hospital, ESIC Medical Campus, Kalaburagi, Karnataka, India-585106
Gulbarga
KARNATAKA |
7418296274
divakarsanthanam17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-ESIC Dental College |
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 |
| Comparator Agent |
Conventional complete denture |
Fabrication of complete denture using conventional techniques and inserted to patients for 3 months |
| Intervention |
Simplified complete denture |
Fabrication of complete denture using simplified technique and inserted to patient for 3 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Completely edentulous maxillary and mandibular arches
Previous complete denture wearers
Severly resorbed mandibular ridge
Possessing an adequate understanding of written and spoken Hindi/Kannada/English.
Able to understand and respond to the questionnaire used in the study
|
|
| ExclusionCriteria |
| Details |
Acute/chronic symptoms of temporomandibular disorders
Uncontrolled systemic diseases
Any oral pathology requiring intervention
Psychological conditions that could influence the patient’s reaction to the treatment
Flabby residual ridges
Smokers and tobacco users
Patients wanting dental implants
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral health–related quality of life (OHRQoL) assessed using the Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) questionnaire at the end of each study period (3 months after denture insertion). |
3 months: End of Period 1
6 months: End of Period 2 (after crossover) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction assessed using a 100-mm horizontal Visual Analogue Scale (VAS) at the end of each study period.
Subjective assessment of denture performance, including:
Comfort
Stability
Chewing efficiency
Overall satisfaction |
3 months: End of Period 1
6 months: End of Period 2 (after crossover) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
18/01/2026 |
| 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="0"
Months="6"
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 randomized, double-blinded, two-period crossover clinical trial aims to compare patient satisfaction and oral health–related quality of life in completely edentulous patients rehabilitated with simplified and conventional complete dentures. The simplified technique uses a chairside visible light-cured resin protocol to fabricate a custom tray and occlusal rims in fewer clinical visits, while the conventional technique follows the traditional multi-visit denture fabrication protocol. Participants are randomly allocated to one of two treatment sequences and receive both types of complete dentures during two study periods. Outcome assessments are performed only after 3 months (end of Period 1) and 6 months (end of Period 2) following denture insertion. Patient-reported outcomes are evaluated using the Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) and a 100-mm Visual Analogue Scale (VAS). The study aims to determine whether simplified complete dentures provide comparable patient satisfaction and oral health–related quality of life when compared with conventional dentures |