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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 

 

 
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