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Clinical Trials/CTRI/2024/06/069695
CTRI/2024/06/069695CompletedPhase 4

Beyond Pills Transdermal patch efficacy in post operative pain relief.

Academy of Medical Education dental college and hospital1 site in 1 country40 target enrollmentStarted: July 10, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
pain reduction post surgery will be evaluated

Study Overview

Brief Summary

Abstract:

Aim:  Assessing the comparative effectiveness of oral diclofenac v/s transdermal diclofenac in patients following periodontal flap surgery.

Methodology: 40 Systemically healthy patients of age 25-50yrs including both sexes requiring periodontal flap surgical procedure were selected.100mg diclofenac sodium SR either orally or transdermally was administered 30mins following the surgery. Pain relief and pain intensity with both the diclofenac formulations was recorded at 0, 6th and 12 hour interval using 5-point Verbal Pain Intensity, Pain Relief Score Charts and visual analogue scale.

Study Design

Study Type
Interventional
Allocation
Other
Masking
None

Eligibility Criteria

Ages
25.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • (1) having good general health, (2) having at least 6 teeth per quadrant, (3) Patients requiring NSAIDs after periodontal flap surgical procedure.

Exclusion Criteria

  • were (1) Subjects with history of allergy to NSAIDs (2) Subjects undergoing treatment with other NSAIDs or any other analgesics or corticosteroids during the trial period and those with history of systemic diseases like bronchial asthma, epilepsy, and emotional and psychosomatic disorders were also excluded (3) Pregnant and lactating females were also excluded (4) H/O drinking or/and smoking.

Outcomes

Primary Outcomes

pain reduction post surgery will be evaluated

Time Frame: pain reduction at 6HRS AND 12HRS | post periodontal flap surgery will be evaluated

Secondary Outcomes

  • REDUCED GASTRIC IRRITATION due to use of transdermal diclofenac(6 HOURS AND 12 HOURS post periodontal flap surgery)

Investigators

Sponsor
Academy of Medical Education dental college and hospital
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

ZUBEIDA HALEEM

A.M.ES Dental College and Hospital Raichur.

Study Sites (1)

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