- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07538375
Effectiveness of Dexamethasone Injection for Reducing Pain After Third Molar Surgery (DEXA-TMS)
Effectiveness of Dexamethasone Injection on Postoperative Pain After Impacted Third Molar Surgery Assessed Using Visual Analog Scale
Study Overview
Status
Intervention / Treatment
Detailed Description
Impacted mandibular third molar surgery is commonly associated with postoperative pain, which can affect patient comfort and recovery. Corticosteroids such as dexamethasone have anti-inflammatory properties and may reduce postoperative pain and swelling.
This randomized clinical trial is designed to compare postoperative pain levels in patients undergoing third molar surgery with and without the administration of dexamethasone. Patients are randomly allocated into two groups. Group 1 receives standard inferior alveolar nerve block using 2% lignocaine with epinephrine. Group 2 receives an additional 1 ml (8 mg) dexamethasone injection in the buccal vestibule after completion of surgery.
Pain is assessed using the Visual Analogue Scale (VAS) at 24, 48, and 72 hours postoperatively. All patients are prescribed the same postoperative analgesic regimen. The primary outcome is the difference in mean pain scores between the two groups. Data analysis is performed using SPSS, and statistical significance is set at p < 0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 63000
- 28 Military Dental Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 20 to 40 years
- Patients with at least one impacted mandibular third molar (Class A or B, Class I or II) including mesioangular, horizontal, vertical, or distoangular impactions according to Pell and Gregory classification confirmed by panoramic radiograph
- Patients with no systemic disease (e.g., diabetes mellitus, hypertension, ischemic heart disease)
- Patients of either gender
Exclusion Criteria:
- Patients who have used analgesics or related drugs within 15 days prior to surgery
- Pregnant patients
- Patients with known allergy to corticosteroids
- Patients with tooth associated with cyst, tumor, or trauma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dexamethasone Group
Dexamethasone 8 mg (1 ml) was administered via buccal vestibular injection immediately after surgical removal of impacted mandibular third molars.
|
Dexamethasone 8 mg (1 ml) was administered via buccal vestibular injection immediately after surgical removal of impacted mandibular third molars.
|
|
No Intervention: Control Group
Participants will receive standard postoperative care without dexamethasone following surgical removal of impacted mandibular third molars.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity
Time Frame: 24 hours, 48 hours, and 72 hours postoperatively
|
Postoperative pain will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst possible pain, following surgical removal of impacted mandibular third molars.
|
24 hours, 48 hours, and 72 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Postoperative Complications
- Pathologic Processes
- Tooth Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Tooth, Impacted
- Polycyclic Compounds
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Pregnadienetriols
- Dexamethasone
Other Study ID Numbers
- MDC-LHR-DEXA-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Children's National Research InstituteVentureWellRecruitingPostoperative Pain | Acute Pain | Acute Pain, PostoperativeUnited States
-
University of ManitobaUnknown
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
Clinical Trials on Dexamethasone
-
Poznan University of Medical SciencesRecruitingHip Pain Chronic | Hip OsteoarthritisPoland
-
Beijing Tiantan HospitalBeijing Ditan Hospital; Beijing Electric Power HospitalNot yet recruiting
-
Poznan University of Medical SciencesNot yet recruitingOsteoarthritis, Hip | Hip OsteoarthritisPoland
-
TheiaNova Ltd.Enrolling by invitation
-
Woman'sRecruitingOral Mucositis Due to ChemotherapyUnited States
-
Shandong UniversityRecruitingPrimary Immune Thrombocytopenia (ITP)China
-
Semnur Pharmaceuticals, Inc.Cromos Pharma LLC; SyngeneNot yet recruitingLumbosacral Radicular Pain
-
Eye & ENT Hospital of Fudan UniversityShanghai Zhongshan Hospital; Shenzhen Second People's HospitalNot yet recruiting
-
Sheffield Children's NHS Foundation TrustRecruitingDexamethasone | Acute AsthmaUnited Kingdom
-
Second Affiliated Hospital, School of Medicine,...West China Hospital; Ningbo Medical Center Lihuili Hospital; Jinhua People's... and other collaboratorsRecruitingInflammatory Bowel Disease (IBD) | UC - Ulcerative Colitis | CD - Crohn's DiseaseChina