Comparing 4 mg versus 8 mg submucosal dexamethasone for pain after single-tooth dental implant surgery
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 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 |
| Enrollment | 138 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Oman Ministry of Health Government |
| Locations | 1 site (Muscat) |
| Trial ID | NCT07413055 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Muscat
- Al Nahdha Hospital — Muscat, Oman (Recruiting)
Study contacts
- Study coordinator: Shurooq Slim Al Hinai, BDS
- Email: shurooqalhinai@gmail.com
- Phone: +968 96148103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.