MedTrace Logo

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

NCT05142098 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2021-12-16

No results posted yet for this study

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

Interventions

DRUG

Dexamethasone

Intramuscular

DRUG

Etoricoxib 60 mg

Orally

Sponsors & Collaborators

  • Dow University of Health Sciences

    lead OTHER

Principal Investigators

  • hassan hafeez · DUHS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-07-01
Completion
2022-08-01

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05142098 on ClinicalTrials.gov