Comparison of Clinical Efficacy of Submucosal Dexamethasone and Oral Trypsin-chymotrypsin for Reduction of Postoperative Sequelae After Lower Third Molar Surgery

Not Applicable

Recruiting

• Conditions: Clinical Efficacy of Submucosal Dexamethasone and Oral Trypsin Chymotrypsin for Reduction of Postoperative Sequelae After Lower Third Molar Surgery
• Interventions: Drug: Dexamethasone; Drug: Chymotrypsin

• Registration Number: NCT06713733
• Lead Sponsor: B.P. Koirala Institute of Health Sciences

Brief Summary

Pain, edema and trismus are the most frequent postoperative sequelae to surgical removal of impacted teeth, all of are due to the local inflammatory response.

Use of corticosteroids decrease tissue mediators of inflammation and reduce edema.

Use of trypsin-chymotrypsin elaborates the enzymes esterase in blood plasma that inhibits inflammation by hydrolytic degradation of the inflammatory peptides.

Detailed Description

Impacted tooth is a tooth which is completely or partially unerupted and is positioned against another tooth, bone or soft tissue so that its further eruption is unlikely, described according to its anatomic position.

Surgical extraction of the impacted mandibular third molars is the most common procedure in oral surgery clinics. Most of the common postoperative complications following lower third molars surgery are pain, trismus and facial swelling. Adequate surgical methods such as selecting an appropriate flap design, minimal bone removal and less trauma to adjacent soft tissues with proper wound closure techniques could decrease the incidence of postoperative sequelae, but not eliminate it.

surgical edema is expected sequel of removal of impacted lower wisdom tooth. Swelling usually reaches at its maximum on 2nd and 3rd postoperatively day and should start reducing by 4th day. Swelling completely resolves by the 7th to 9th day.

Corticosteroids are routinely employed to control the sequelae of inflammation in third molar surgeries. Steroids prevent diapedesis, the initial leakage of fluids from the capillaries, and stabilize the membranes of the cellular lysosomes which hold large quantities of hydrolytic enzymes. There is also a decrease in the formation of bradykinin, a powerful vasodilating substance. Steroids act by suppression of leucocyte and macrophage accumulation at the inflammatory site by interfering with capillary dilatation, fibrin deposition and prevention of prostaglandin synthesis by inhibiting the arachidonic acid cascade.

Trypsin-chymotrypsin is proteolytic enzymes that acts as anti-inflammatory agents. The concentration of enzymes determined as esterase in blood plasma is increased after trypsin chymotrypsin administration. Since the inflammatory process is thought to be due to peptides elaborated at the site of tissue trauma, it has been postulated that the increased blood esterase due to trypsin chymotrypsin administration inhibits inflammation by hydrolytic degradation of the inflammatory peptides.

Study Timeline

• Study Start: 2024-09-25
• Status Verified: 2024-11
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Primary Completion: 2024-12-25
• Study Completion: 2025-01-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Clinically healthy patients (ASA I) patient free of any systemic diseases that could interfere with wound healing or surgical operation.
• Free of any recent anti-inflammatory drug intake or being under long term treatment with medicaments that will obscure the assessment of the inflammatory response as NSAIDs, steroids, or antihistamines
• Free from allergy to the drugs used in the study
• Patients requiring surgical removal of the mandibular impacted third molar

Exclusion Criteria

• Patients who are ASA II to ASA VI.
• Patients already on corticosteroids through any route.
• Patients with known allergy to any drugs.
• Pregnant and lactating females
• Patient not consenting to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	submucosal dexamethasone is quite simple, less invasive, painless, convenient for the surgeon and offers a low cost solution. Submucosal injection offers advantage of concentrating the drug near the surgical area with less systemic absorption and no further manipulation of the tissues. preoperative submucosal dexamethasone 8mg prior to incision locally.
Chymotrypsin	Chymotrypsin	oral trypsin chymotrypsin is proteolytic enzymes. 1 tab given 30 minutes prior to incision and 1 tab for three times a day for 5 days after extraction.

Primary Outcome Measures

Name	Time	Method
comparison of clinical efficacy of submucosal dexamethasone and oral trypsin-chymotrypsin for reduction of postoperative sequelae after lower third molar surgery	3 months	previous study had shown submucosal dexamethasone is more effective than oral trypsin chymotrypsin

Trial Locations

Locations (1)

Bp Koirala Institute of Health Sciences; 🇳🇵 Dharān Bāzār, Koshi, Nepal