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NCT Number: NCT07413055

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.

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Key information

Conditions

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

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Al Nahdha Hospital

Muscat, Oman

Location status: Recruiting

Location contact

Nasser Al Khaldi, Senior Consultant Prostho

CONTACT

[email protected]

+968 92898987

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone 4 Mg/mL Injectable Solution

Drug

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

Dexamethasone 8Mg Solution for Injection

Drug

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

Saline (NaCl 0,9 %) (placebo)

Drug

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

Primary outcomes

  1. Postoperative pain assessed using Visual Analog Scale (VAS)

    Time frame: at 6 hours postoperatively and then once daily for the following 6 days

    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

Secondary outcomes

  1. Number of postoperative analgesic tablets consumed

    Time frame: Postoperatively for 7 days

    The total number of rescue analgesic tablets consumed postoperatively will be recorded daily following the implant surgery

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nasser Al Khaldi, Senior Consultant Prosth

CONTACT

[email protected]

+ 968 92898987

Shurooq Slim Al Hinai, BDS

CONTACT

[email protected]

+968 96148103

Sponsors and collaborators

Lead sponsor

Oman Ministry of Health

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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