drugset / Trial / NCT02763059

Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement

NCT02763059 ↗

Phase 4 Completed 132 enrolled King Abdulaziz University
RandomizedParallel-groupTriple-blindPrevention

Summary

Background and aim: Postoperative pain is an adverse effect of oral surgeries and may therefore be prevented or minimized. This study compares the efficacy of preemptive ibuprofen and dexamethasone protocols in pain prevention and control after surgical implant placement. Methods: For this prospective, double-masked, parallel-group, placebo-controlled, randomized clinical trial, 117 dental implants were placed. The groups received three different protocols 1 hour before surgery: 1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose); 2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or 3. placebo. Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. Pain intensity was evaluated by a 101-point numeric rate scale and visual analogue scale, additionally discomfort was evaluated using a four-point verbal rate scale, hourly for the first 8 hours after surgery and three times a day on the following 3 days.

Timeline

Start
2013-09
Primary completion
2015-05
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 4 mg —
Comparator Ibuprofen Small molecule 600 mg —
Comparator Acetaminophen Small molecule 1000 mg —

Indications

No indication recorded.