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

NCT07413055 | Recruiting Phase 3

• 1 other identifier: MoH/CSR/25/29882
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

Dexamethasone; Dental implants; Postoperative pain; Submucosal injection; Analgesic consumption; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of postoperative analgesic tablets consumed

  Postoperatively for 7 days

• Correlation between preoperative anxiety (GAD-7) and postoperative pain score

  Anxiety will be assessed preoperatively on the day of the surgery before implant placement

Study Arms (3)

8mg Dexamethasone

EXPERIMENTAL

8mg/2ml dexamethasone injection.

Drug: Dexamethasone 8Mg Solution for Injection

4mg Dexamethasone

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

2 ml of sterile normal saline for injection.

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

Dexamethasone 4 Mg/mL Injectable Solution DRUG

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

4mg Dexamethasone

Dexamethasone 8Mg Solution for Injection DRUG

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

8mg Dexamethasone

Saline (NaCl 0,9 %) (placebo) DRUG

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

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oman Ministry of Health: lead

Study Sites (1)

Al Nahdha Hospital

Muscat, Oman

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Interventions

Dexamethasone; Solutions; Injections; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Shurooq Slim Al Hinai, BDS

CONTACT

+968 96148103; shurooqalhinai@gmail.com

Nasser Al Khaldi, Senior Consultant Prosth

CONTACT

+ 968 92898987; dent2020@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

OM (1)