CTRI/2025/08/093633Not yet recruitingPhase 1/2
Comparative Evaluation of Chewing Efficiency and Nutritional Status in the Dentures Fabricated using Bioelectric Impression to Conventional Impression: A Randomized Clinical Trial
Sapna Rani1 site in 1 country20 target enrollmentStarted: September 8, 2025Last updated:
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Chewing efficiency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 45.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients with ridge defects
- •Patients with any systemic disease that contraindicates electrode placement, e.g., cardiac pacemaker, etc.
- •Patients with poor neuromuscular control, temporomandibular joint pain, psychological disorder.
- •Patients with a single complete denture.
Outcomes
Primary Outcomes
Chewing efficiency
Time Frame: Chewing efficiency after 1 week of insertion
Secondary Outcomes
- Nutritional status(pre-denture insertion and 3 months post-denture insertion)
Investigators
Sapna Rani
Professor, Manav Rachna Dental College,SDS, MRIIRS
Study Sites (1)
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