Phase 4
N=132
Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement
Pain Measurement
Bottom Line
View on ClinicalTrials.gov: NCT02763059 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain. — 2; 2; 5.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ibuprofen 600 mg (Drug); Dexamethasone 4 mg (Drug); Placebo (Drug); Acetaminophen 1000 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- King Abdulaziz University
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain. |
2; 2; 5.0 | — |
| SECONDARY the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain. |
5; 6; 39 | — |
| SECONDARY The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort. |
1; 1; 2 | 0.027 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Informed consent for the described procedure
- Surgical placement of a single endosteal implant
- Age of at least 18 years
Exclusion Criteria
- The need for bone grafting or sinus lift for implant placement
- Pregnant and lactating women
- Metabolic disorders
- Immunocompromised status
- Hemophilia or bleeding disorders
- Drug or alcohol abuse
- Treatment with steroids in the previous 6 months
- History of radiation therapy in the head and neck
- Psychiatric disorders
- Inability to understand the procedure described in the questionnaire
Data sourced from ClinicalTrials.gov (NCT02763059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.