A comparative study to evaluate the anti-inflammatory and analgesic activity of flavonoids and serratiopeptidase in patients undergoing mandibular third molar surgeryâ€“A Randomized Controlled Trial

Not yet recruiting

Conditions: Disturbances in tooth eruption,

Registration Number: CTRI/2023/05/052286

Lead Sponsor: Dr Nitin B

Brief Summary: Surgical removal of mandibular third molar is usually associated with postsurgical sequalae that may have both biological and social impact.

Patients report common post-operative complications such as pain, swelling and trismus which affects the quality of life.

Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions

Serratiopeptidase is a widely used proteolytic enzyme in therapeutic applications. It has shown significant anti-inflammatory, anti-edemic, and analgesic effects in various areas including surgery, orthopaedics, otorhinolaryngology, gynaecology, and dentistry. It is well known amongst researchers for its caseinolytic (proteolytic) and fibrinolytic properties.

Combination of Proteolytic enzyme with Flavonoids that includes trypsin, bromelain and rutoside showed increased significance in reduction of pain and inflammation.

Studies have shown that using a proteolytic enzyme aids a better and fast healing when compared to usual anti-inflammatory drugs hence this study is done to find the anti-inflammatory and analgesic activity in combination of Enzyme and NSAIDs

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 92

Inclusion Criteria

ASA I patients in the age group of 18- 40 years with either gender 2.
All impacted mandibular third molars requiring surgical extraction 3.
CLASS I, CLASS II, POSITION-A and POSITION-B Impacted third molar According to Pell and Gregory classification 4.Patient willing to participate in the study.

Exclusion Criteria

1.Acute infection 2.Patient allergic to administrated drugs 3.Patients with Gastric Ulcers 4.Patient with bleeding disorders 5.Pregnancy and Lactating women 6.Immunocompromised patient Mentally challenged patient.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Outcome: Swelling and Trismus	Both Primary and Secondary outcomes are measured on the pre operative day (Day 0) and post operative days (Day 1and Day 3) that is during the course of the intervention administered and post operative days (Day 7 and Day 12) for follow up
Primary Outcome: Pain	Both Primary and Secondary outcomes are measured on the pre operative day (Day 0) and post operative days (Day 1and Day 3) that is during the course of the intervention administered and post operative days (Day 7 and Day 12) for follow up

Secondary Outcome Measures

Name	Time	Method
Primary Outcome: Pain	Secondary Outcome: Swelling and Trismus
Swelling	Trismus

Trial Locations

Locations (1): Sri Venkateshwaraa Dental College
🇮🇳
Pondicherry, PONDICHERRY, India
Sri Venkateshwaraa Dental College
🇮🇳Pondicherry, PONDICHERRY, India
Dr Nitin B
Principal investigator
8903387423
writetonitinbabu@gmail.com