CTRI/2024/09/074172CompletedPhase 2
Evaluating the Efficacy of Twin Mixed Local Anaesthesia and Local Anaesthesia with Submucosal Dexamethasone Injection in Mandibular Third Molar Surgery – Prospective Comparative Clinical Trial
Karthiga M1 site in 1 country39 target enrollmentStarted: October 4, 2024Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- POST OPERATIVE PAIN, FACIAL SWELLING AND MOUTH OPENING
Study Overview
Brief Summary
This is a prospective clinical trial with computer based randomisation to access pain during injection, onset and duration of analgesia, post operative pain, mouth opening and facial swelling. There is difference in pain during injection, onset of anaesthesia, duration of analgesia, reduction of postoperative pain, facial swelling followed by improvement in mouth opening.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 21.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects above the age of 21 with mesioangular impacted mandibular third molar of Pell & Gregory Class-I, Level A.
- •Subjects who are in good physical status.
- •Subjects who could understand and are willing to take part in the study and likely to comply with all study procedures.
Exclusion Criteria
- •Refusal to participate in the study.
- •Pregnancy and lactation.
- •Patient having systemic disorder like diabetes, hypertension, cardiac or neurological disorder.
- •Patients with reduced mouth opening (mouth opening above 30mm was considered normal) Patient with history of drug allergy to lignocaine, dexamethasone, amoxicillin, metronidazole, diclofenac.
- •Patients with active infection.
- •Patient under any antibiotics or analgesics coverage.
- •Patient other than Pell & Gregory Class-I Level A.
- •Patients with severe oral manifestations of systemic disease.
- •Psychologic or psychiatric conditions that could influence response to treatment.
Outcomes
Primary Outcomes
POST OPERATIVE PAIN, FACIAL SWELLING AND MOUTH OPENING
Time Frame: 7 days
Secondary Outcomes
- INTRAOPERATIVE PAIN(3 HOURS)
- POST OPERATIVE PAIN, FACIAL SWELLING AND MOUTH OPENING(3rd day, 7th day)
Investigators
Karthiga M
Sri Balaji Vidyapeeth
Study Sites (1)
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