CTRI Number |
CTRI/2024/04/065072 [Registered on: 02/04/2024] Trial Registered Prospectively |
Last Modified On: |
12/07/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Preventive |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of retention and oral health quality of life in complete denture patients using two different impression techniques for denture fabrication |
Scientific Title of Study
|
Comparative Evaluation of Retention and Oral Health Quality of Life in Dentures Fabricated with Conventional Impression Technique and Transcutaneous Electric Nerve Stimulation: A Prospective Clinical study |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sapna Rani |
Designation |
Professor |
Affiliation |
Manav Rachna Dental College |
Address |
Department of Prosthodontics, Manav Rachna Dental college, SurajKund Badhkal road, Sector-43
Faridabad HARYANA 121004 India |
Phone |
8375899663 |
Fax |
|
Email |
drsapnadaksh@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Sapna Rani |
Designation |
Professor |
Affiliation |
Manav Rachna Dental College |
Address |
Manav Rachna Dental college, SurajKund Badhkal road, Sector-43
HARYANA 121004 India |
Phone |
8375899663 |
Fax |
|
Email |
drsapnadaksh@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Sapna Rani |
Designation |
Professor |
Affiliation |
Manav Rachna Dental College |
Address |
Department of Prosthodontics, First floor, Manav Rachna Dental college, SurajKund Badhkal road, Sector-43
HARYANA 121004 India |
Phone |
8375899663 |
Fax |
|
Email |
drsapnadaksh@gmail.com |
|
Source of Monetary or Material Support
|
Manav Rachna Dental College, Faridabad, Haryana, India-121010 |
|
Primary Sponsor
|
Name |
Manav Rachna Dental College, MRIIRS |
Address |
Surajkund Badhkal road, Sector-43 |
Type of Sponsor |
Research institution |
|
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 Sapna Rani |
Manav Rachna Dental College |
First floor, Room no 4, Department of Prosthodontics, Manav Rachna Dental College, Surajkund Badhkal Road, Sector 43 Faridabad HARYANA |
8375899663
drsapnadaksh@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethical committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Completely Edentulous |
Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Secondary impression technique |
Transcutaneous electric nerve stimulation for border molding and final impression. |
Intervention |
TENS |
TENS in border molding for completely edentulous patients for 40 minutes |
|
Inclusion Criteria
|
Age From |
45.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Completely edentulous patients in need of dentures
No need of pre-prosthetic surgery
Patients with healed residual ridges
patients ready for follow-up
|
|
ExclusionCriteria |
Details |
Patients with ridge defects
Patients with any systemic disease which contraindicates electrode placement e.g. cardiac pacemaker etc.
Patients with poor neuromuscular control, temporomandibular joint pain, Psycholgical disorder.
Patients with single complete denture
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. To evaluate and compare retention in dentures fabricated with conventional impression method and TENS in completely edentulous patients. |
at baseline (at the time of insertion) for both dentures |
|
Secondary Outcome
|
Outcome |
TimePoints |
2. To measure and compare OHI-Edent in dentures fabricated with conventional impression method and TENS in completely edentulous patients. |
At the time of insertion, 3 months after insertion |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
16/04/2024 |
Date of Study Completion (India) |
14/11/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Will be Published in Jan-Feb issue of Journal of Oral Biology and Craniofacial Research |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Aim: The aim of the present study was to comparatively evaluate the retention of complete dentures and oral health-related quality of life (OHRQoL) of patients with conventional and bioelectric impressions or transcutaneous electric nerve stimulation (TENS). Materials and Methods: A total of thirty (n=30) completely edentulous patients were randomly distributed into two groups: Group-C (n=15) (Conventional) and Group-T (n=15) (bioelectric) according to consort guidelines. In Group C, border molding was performed using the manual manipulation of borders, and the final impression was made using zinc-oxide eugenol. In Group T, border molding and final impression were performed with the TENS application. Dentures were fabricated, and retention was evaluated with a digital gauge. OHRQoL was assessed at the time of insertion and after three months of follow-up using the Oral Health Impact Profile Edentulous in Hindi (OHIP-Edent-H) questionnaire. A two-way ANOVA test was used for the significance level (P<0.05). Student t-test was used for intergroup comparison, and paired t-test was used for intragroup comparison of OHRQoL. Results: There was no significant difference in the retention of maxillary and mandibular dentures fabricated with both techniques (P=0.283, P=0.662). Although, OHRQoL increased significantly in both groups at follow-up (P=.001). However, at follow-up, the Functional Limitation (FL) domain was significantly better in the conventional group. Conclusions. Although, there was no significant difference in retention and OHRQoL between both groups. However, to reach a conclusive result, more clinical trials with large samples and longer follow-ups are required. |