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

November 27, 2024 updated by: DR. SABIN BANIYA, B.P. Koirala Institute of Health Sciences

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Nepal
    • Koshi
      • Dharān Bāzār, Koshi, Nepal
        • Recruiting
        • BP Koirala Institute of Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Dexamethasone
local infiltration
Other Names:
  • submucosal dexamethasone
Active Comparator: 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.
Drug: Chymotrypsin
orally given
Other Names:
  • oral trypsin chymotrypsin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.P. Koirala Institute of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2024

Primary Completion (Estimated)

December 25, 2024

Study Completion (Estimated)

January 25, 2025

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRC/2765/024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe