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

NCT02763059 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-11-13

Study results available
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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.

Conditions

  • Pain Measurement

Interventions

DRUG

Ibuprofen 600 mg

This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);

DRUG

Dexamethasone 4 mg

This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)

DRUG

Placebo

This group receives 1 hour before surgery placebo.

DRUG

Acetaminophen 1000 mg

A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.

Sponsors & Collaborators

  • King Abdulaziz University

    lead OTHER

Principal Investigators

  • Maha Bahammam, Sc, CAGS, EdM, DABP · King Abdulaziz University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-05-31
Completion
2016-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02763059 on ClinicalTrials.gov