A clinical study to compare pain reduction effect of diclofenac sodium mouthwash with diclofenac sodium tablet after gum surgery; a pilot study.

Completed

• Conditions: Patients indicated for periodontal surgeries.

• Registration Number: CTRI/2018/01/011365

Brief Summary

**Introduction:** Local drug deliveryis well known for its advantages over systemic drug therapy. Among NSAID’s,Diclofenac is most commonly used analgesic and anti-inflammatory agent. Itsmouthwash preparation has gained attention but there has not been anycross-over study reported in literature. 

**Materialand methods:** Ten patients, indicated for periodontal surgeries, randomlyreceived diclofenac mouthwash for 1 min, twice daily for 4 days or diclofenactablet twice daily for 4 days. After atleast 15 days second surgery wasperformed and mode of therapy was switched. Patient was asked to score NRSindex either personally or telephonically for those 4 days. Collected data wastabulated and analysed.

**Hypothesis:** After periodontal surgery diclofenac sodium localapplication (0.074% mouthwash) will have equal analgesic effect as compared toits systemic administration (tablet).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-28
• Study Completion: 2017-11-24
• Last Update Posted: 2018-01-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 1.Systemically healthy patients.
• 2.Patients indicated for periodontal surgeries.

Exclusion Criteria

• 1.Patients with the history of intolerance or hypersensitivity to diclofenac.
• 2.Any systemic diseases or condition that affects the oral tissues, 3.Pregnant or lactating women.
• 4.Patients on oral/systemic NSAIDs therapy for the last three months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Topical formulation of diclofenac sodium will be sufficiently effective for pain relief after periodontal surgical procedures when compared to systemic formulation of diclofenac sodium.	Analgesic effect will checked on 1st 2nd 3rd and 4th day after surgery by NRS index.

Trial Locations

Locations (1)

MGVs KBH Dental college and Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

MGVs KBH Dental college and Hospital

🇮🇳Nashik, MAHARASHTRA, India

Dr Shreeprasad V Wagle

Principal investigator

8308068269

svw1593@gmail.com