Comparing 4 mg versus 8 mg submucosal dexamethasone for pain after single-tooth dental implant surgery
Official title: 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
Run by Oman Ministry of Health · NCT07413055 · Data updated 2026-11-12
This will see if a 4 mg or 8 mg dexamethasone injection under the gum reduces pain after single-tooth dental implant surgery compared with a saline injection.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Enrollment | 138 (estimated) |
| Sponsor | Oman Ministry of Health Government |
| Locations | 1 site (Muscat) |
| Status | Recruiting |
| Started | March 25, 2026 |
| Main results expected | November 15, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT07413055 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21–80, ASA I–II, scheduled for a single-tooth type 3 or type 4 implant, who are not pregnant or lactating, are non-smokers/non-alcoholics, and do not require bone grafting or antibiotic prophylaxis.
✕Probably not a fit
Patients needing bone augmentation or sinus lifting, those who require antibiotic prophylaxis, smokers/alcoholics, pregnant or breastfeeding people, and those with allergies to study medications are not expected to benefit from or be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind, placebo-controlled Phase 3 trial at Al Nahdha Hospital in Muscat enrolls adults receiving a single-tooth implant and randomly assigns them to a 4 mg dexamethasone submucosal injection, an 8 mg injection, or saline placebo at the surgical site. Postoperative pain is measured with a Visual Analog Scale at 6 hours and daily for six days, and the number of analgesic tablets taken is recorded. Preoperative anxiety is measured using the GAD-7 to explore its relationship with postoperative pain. The trial excludes patients needing bone augmentation/sinus lift, those requiring antibiotic prophylaxis, smokers, pregnant or lactating people, and those with relevant medication allergies.
Why it matters
Potential benefit: If successful, the trial could identify an optimal local dexamethasone dose that reduces pain and lowers postoperative painkiller use after dental implant surgery.
How similar studies have gone: Previous trials of local corticosteroids in oral surgery have generally reduced pain and swelling, but the optimal submucosal dexamethasone dose after dental implant placement remains unclear.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Al Nahdha Hospital
Muscat, Oman Recruiting
Study contacts
- Study coordinator: Shurooq Slim Al Hinai, BDS
- Email: shurooqalhinai@gmail.com
- Phone: +968 96148103
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.