RecruitingPhase 3NCT07413055

Comparative Efficacy Of 4 mg VS. 8 mg Submucosal Dexamethasone In Postoperative Pain Management After Dental Implant Surgery: A Randomized Double-Blind Controlled Clinical Trial

Comparative Efficacy of 4 mg vs. 8 mg Submucosal Dexamethasone in Postoperative Pain Management After Dental Implant Surgery: A Randomized Double-Blind Controlled Clinical Trial


Sponsor

Oman Ministry of Health

Enrollment

138 participants

Start Date

Mar 25, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to compare the effectiveness of 4mg and 8mg dexamethasone administered submucosally in reducing postoperative pain after dental implant surgery. Participants will be randomly assigned to receive either 4mg dexamethasone, 8mg dexamethasone, or a placebo (normal saline) at the surgical site. Later, postoperative pain will be assessed using a Visual Analog Scale at 6 hours after the surgery and daily for the next 6 days. Also the number of pain-relief tablets consumed after the surgery will be recorded. Preoperative anxiety will be assessed using Generalized Anxiety Disorder-7 (GAD-7) questionnaire to assess its association with postoperative pain scores. The results of this study will help determine the optimal dose of dexamethasone that is effective for postoperative pain control following dental implant surgery.


Eligibility

Min Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two doses of dexamethasone (a steroid given to reduce swelling and pain) — 4 mg versus 8 mg — to find out which dose better controls pain after dental implant placement surgery. **You may be eligible if...** - You are between 21 and 80 years old (male or female) - You are generally healthy or have only mild systemic disease (ASA I or II) - You are having a single dental implant placed in a standard delayed or late-stage procedure **You may NOT be eligible if...** - You have a known allergy to any medications to be used in the study - You smoke or drink alcohol regularly - You are pregnant or breastfeeding - You need bone grafting or sinus lifting as part of the implant surgery - You require antibiotics before dental procedures (antibiotic prophylaxis) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexamethasone 4 Mg/mL Injectable Solution

Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule

DRUGDexamethasone 8Mg Solution for Injection

Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule

DRUGSaline (NaCl 0,9 %) (placebo)

Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule


Locations(1)

Al Nahdha Hospital

Muscat, Oman

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NCT07413055


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