NCT05142098

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

Status unknown EARLY_PHASE1 Last updated 16 December 2021

What this trial tests

EARLY_PHASE1 trial testing Dexamethasone in Effect of Drug in 170 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
1 July 2022

1 August 2022

Quick facts

Lead sponsor	Dow University of Health Sciences
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	170
Start date	1 January 2022
Primary completion	1 July 2022
Estimated completion	1 August 2022

Drugs / interventions tested

• Dexamethasone (dexamethasone) — full drug profile →
• Etoricoxib 60 mg — full drug profile →

Conditions studied

• Effect of Drug — all drugs for Effect of Drug →

Sponsor

Dow University of Health Sciences

Who can join

Adults 18 to 35, any sex, with Effect of Drug. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Selective COX-2 Inhibitors: Road from Success to Controversy and the Quest for Repurposing.
   El-Malah AA, Gineinah MM, Deb PK, Khayyat AN, et al · · 2022 · cited 48× · PMID 35890126 · DOI 10.3390/ph15070827