| CTRI Number |
CTRI/2025/08/093633 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of Chewing Efficiency and Nutritional Status in the Dentures Fabricated with Conventional Impression and Bioelectric Impression |
|
Scientific Title of Study
|
Comparative Evaluation of Chewing Efficiency and Nutritional Status in the Dentures Fabricated using Bioelectric Impression to Conventional Impression: A Randomized 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 |
Sapna Rani |
| Designation |
Professor |
| Affiliation |
Professor, Manav Rachna Dental College,SDS, MRIIRS |
| Address |
Room no 4, Q block, SDS, MRIIRS
Faridabad
HARYANA
121003
India |
| Phone |
08375899663 |
| Fax |
|
| Email |
drsapnadaksh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sapna Rani |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room no 4, Q block, SDS, MRIIRS
Faridabad
HARYANA
121003
India |
| Phone |
08375899663 |
| Fax |
|
| Email |
drsapnadaksh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sapna Rani |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room no 4, Q block, SDS, MRIIRS
house no 144, ground floor, IP colony, Faridabad
Faridabad
HARYANA
121003
India |
| Phone |
08375899663 |
| Fax |
|
| Email |
drsapnadaksh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Prosthodontics, SDS, MRIIRS |
|
|
Primary Sponsor
|
| Name |
Sapna Rani |
| Address |
Room no 4, Q block, SDS, MRIIRS, Faridabad, Haryana-121004 |
| 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 |
| SAPNA |
Manav Rachna Dental College |
Room no 4, SDS, MRDC, MRIIRS, Faridabad, Haryana-121004
Faridabad
HARYANA |
08375899663
sapnarani.sds@mrei.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Completely edentulous patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioelectric impression |
Bioelectric impression (TENS) will be made for another group to fabricate dentures. TENS therapy will be given to patients for 40 minutes during impression making. |
| Comparator Agent |
conventional impression |
Conventional impression will be made for another group for complete denture fabrication |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a. Patient with upper and lower edentulous arches
b. Patient with healed ridge
c. Patient who are ready for follow-up
d. Patients with age 45-65 years
|
|
| ExclusionCriteria |
| Details |
1. Patients with ridge defects
2. Patients with any systemic disease that contraindicates electrode placement, e.g., cardiac pacemaker, etc.
3. Patients with poor neuromuscular control, temporomandibular joint pain, psychological disorder.
4. Patients with a single complete denture
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Chewing efficiency |
Chewing efficiency after 1 week of insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nutritional status |
pre-denture insertion and 3 months post-denture insertion |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="0"
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
|
Complete dentures will be fabricated by two techniques: Conventional border molding and impression technique and Border molding and impression making using TENS technique Chewing efficiency will be measured by EMG with different consistencies of food provided to the patient. Nutritional status will be assessed by a questionnaire (MNA-SF). Statistical analysis will be done. |