Comparison of the Anti-Inflammatory Efficacy of Preemptive Dexamethasone and Etoricoxib

NCT05142098 | Unknown Early Phase 1 DMC

• 1 other identifier: hassan321
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

Impaction of mandibular third molars is a commonly encountered problem in oral surgery; patients frequently visit dental OPDs with complains related to the impacted molars, and in almost all situations, surgical removal of these impactions is the definitive treatment provided to such patients. This type of surgery often involves osteotomies and tooth sectioning, that initiates acute inflammatory responses which results in significant amount of postoperative discomfort owing to the associated pain, swelling and trismus; which considerably affects the quality of life that may span from days up to weeks in few instances. In the past decades, different group of medications have been used to counter these adverse postoperative sequelae, such as steroidal anti-inflammatory drugs (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs). MATERIAL AND METHODS: Study design: Randomized, double-blind, clinical trial with a split-mouth design. Setting: The study would be conducted at Oral \& Maxillofacial Surgery department, Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences, Karachi. Duration of study: Six months after the approval of synopsis. Sample size: A total of 170 patients would be included in the study, i.e. 85 in each group with 2 patients as a drop out. Calculated sample size is 83 patients per group; utilizing Pass version 11 software with 95% confidence interval, mean ± S.D of swelling in dexamethasone group1 95.7 ± 11.1 and in etoricoxib group1 100.0 ± 8.3 at measurement 5. Sampling technique: Purposive non-probability sampling technique would be used for the selection of patients. Sample selection: Patients meeting the following criteria would be included in the study: 1. Age 18-35 years. 2. Absence of any systemic disease. 3. Mandibular third molars in similar position with similar root formation. 3. No use of any medication in last 03 days. 4. Absence of allergy to any drug used in the study. 5. Surgical site with no current signs or symptoms of infection. Patients meeting any of the following criteria would be excluded from the study: 1. Pregnancy or lactation. 2. History of gastrointestinal bleeding or peptic ulcer. 3. Current smoking habit.

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (2)

• assessment of post operative complications after dexamethasone

  dexamethasone is more effective in controlling post operative pain, swelling and trismus following impacted third molar surgery.

  within one week after procedure

• assessment of post operative complications after etoricoxib

  Etoricoxib is more effective in controlling post operative pain, swelling and trismus following impacted third molar surgery.

  within one week after procedure

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 4mg will be injected intramuscularly into the pterygomandibular space after achieving effective inferior dental block.

Drug: Dexamethasone

Etoricoxib

EXPERIMENTAL

2 tablets 60mg each would be given orally one hour prior to the surgery.

Drug: Etoricoxib 60 mg

Interventions

Dexamethasone DRUG

Intramuscular

Also known as: Glucocorticoid

Dexamethasone

Etoricoxib 60 mg DRUG

Orally

Also known as: Cox-2 Inhibitor

Etoricoxib

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-35 years.
• Absence of any systemic disease.
• Mandibular third molars in similar position with similar root formation.
• \. No use of any medication in last 03 days. 4. Absence of allergy to any drug used in the study. 5. Surgical site with no current signs or symptoms of infection.

You may not qualify if:

• Pregnancy or lactation.
• History of gastrointestinal bleeding or peptic ulcer.
• Current smoking habit.
• Patient encountering any complication during/after procedure.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

MeSH Terms

Interventions

Dexamethasone; Glucocorticoids; Etoricoxib; Cyclooxygenase 2 Inhibitors

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• hassan hafeez

  DUHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HASSAN HAFEEZ

CONTACT

03332726607; hassankhandentist@gmail.com

HASSAN HAFEEZ

CONTACT

03138556993; hassankhandentist@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: December 2, 2021
• Study Start: January 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share