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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Dexamethasone 8Mg Solution for Injection; Drug: Dexamethasone 4 Mg/mL Injectable Solution; Drug: Saline (NaCl 0,9 %) (placebo)

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shurooq Slim Al Hinai, BDS; Phone Number: +968 96148103; Email: shurooqalhinai@gmail.com
• Study Contact Backup: Name: Nasser Al Khaldi, Senior Consultant Prosth; Phone Number: + 968 92898987; Email: dent2020@gmail.com

Study Locations

• Oman
  • Muscat, Oman
    • Recruiting
    • Al Nahdha Hospital
    • Contact: Nasser Al Khaldi, Senior Consultant Prostho; Phone Number: +968 92898987; Email: dent2020@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males & females
• Age range (21-80)
• ASA I & II according to (American Society of Anesthesiologists) classification
• Single tooth implant
• Type 3 & type 4 implant placement timing (Chen and Buser, 2009)

Exclusion Criteria:

• Any known allergy to any medications which will be used in the study
• Smokers/ Alcoholics
• Pregnant and lactating women
• Bone augmentation/ sinus lifting required during the surgery
• The need of antibiotic prophylaxis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 8mg Dexamethasone; 8mg/2ml dexamethasone injection.	Drug: Dexamethasone 8Mg Solution for Injection; Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule
Experimental: 4mg Dexamethasone; 4mg/1ml Dexamethasone ampoule + 1ml of sterile normal saline for injection. Mixing dexamethasone with sterile normal saline for injection is considered safe and has no effect on drug potency and efficacy based on current evidence.	Drug: Dexamethasone 4 Mg/mL Injectable Solution; Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule
Placebo Comparator: Placebo; 2 ml of sterile normal saline for injection.	Drug: Saline (NaCl 0,9 %) (placebo); Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain assessed using Visual Analog Scale (VAS)	Postoperative pain will be assessed using a 10-cm visual analog scale in patients following single dental implant surgery after submucosal administration of dexamethasone or placebo	at 6 hours postoperatively and then once daily for the following 6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of postoperative analgesic tablets consumed	The total number of rescue analgesic tablets consumed postoperatively will be recorded daily following the implant surgery	Postoperatively for 7 days
Correlation between preoperative anxiety (GAD-7) and postoperative pain score	Anxiety will be assessed preoperatively using Generalized Anxiety Disorder-7 questionnaire. The relationship between preoperative anxiety scores and postoperative VAS following dental implant surgery will evaluated.	Anxiety will be assessed preoperatively on the day of the surgery before implant placement

Collaborators and Investigators

• Sponsor: Oman Ministry of Health

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Dental implants; Anxiety; Dexamethasone; Postoperative pain; Submucosal injection; Analgesic consumption
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Anxiety Disorders; Pharmaceutical Preparations; Therapeutics; Drug Administration Routes; Drug Therapy; Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Sodium Compounds; Chlorides; Hydrochloric Acid; Dexamethasone; Injections; Solutions; Sodium Chloride
• Other Study ID Numbers: MoH/CSR/25/29882

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No