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NCT Number: NCT06713733

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bp Koirala Institute of Health Sciences

Dharān, Koshi, Nepal

Location status: Recruiting

Location contact

BP KOIRALA INSTITUTE OF HEALTH SCIENCES

CONTACT

[email protected]

+977-9802330760

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

local infiltration

Other names: submucosal dexamethasone

Chymotrypsin

Drug

orally given

Other names: oral trypsin chymotrypsin

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

sabin baniya, mds

CONTACT

[email protected]

+977-9841134900

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.