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

NCT06713733 | Recruiting

• 1 other identifier: IRC/2765/024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Dexamethasone; Trypsin-chymotrypsin

Outcome Measures

Primary Outcomes (1)

• comparison of clinical efficacy of submucosal dexamethasone and oral trypsin-chymotrypsin for reduction of postoperative sequelae after lower third molar surgery

  previous study had shown submucosal dexamethasone is more effective than oral trypsin chymotrypsin

  3 months

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

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

Chymotrypsin

ACTIVE COMPARATOR

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

Interventions

Dexamethasone DRUG

local infiltration

Also known as: submucosal dexamethasone

Dexamethasone

Chymotrypsin DRUG

orally given

Also known as: oral trypsin chymotrypsin

Chymotrypsin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

Bp Koirala Institute of Health Sciences

Dharān, Koshi, Nepal

RECRUITING

MeSH Terms

Interventions

Dexamethasone; Chymotrypsin; chymotrypsin, trypsin drug combination

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases

Central Study Contacts

sabin baniya, mds

CONTACT

+977-9841134900; sabinmds785@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: PI does not have access to any of the groups. i.e PI is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.SABIN BANIYA

Model Details: group a - submucosal dexamethasone group b - oral trypsin chymotrypsin

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: September 25, 2024
• Primary Completion: December 25, 2024
• Study Completion: January 25, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

NE (1)