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

October 29, 2025 updated by: Maha A. Bahammam, King Abdulaziz University

Comparison Between Dexamethasone and Ibuprofen on Postoperative Pain Prevention and Control Following Surgical Implant Placement: a Double-Blind, Parallel-Group, Placebo-Controlled Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective clinical trial investigated the efficacy of preemptive medication in mitigating postoperative pain following dental implant surgeries. With a sample size of 117 participants, the study employed a double-masked, parallel-group, placebo-controlled design. Patients were randomly assigned to receive one of three treatment protocols-an ibuprofen regimen, a dexamethasone regimen, or a placebo-administered one hour before surgery. Pain intensity and discomfort were assessed using numeric, visual, and verbal scales hourly for the first 8 hours post-surgery, followed by thrice-daily evaluations for the next 3 days. Additionally, rescue medication (acetaminophen) was provided to manage pain as needed. The study aimed to determine whether ibuprofen or dexamethasone could effectively alleviate postoperative pain compared to a placebo to highlight optimal pain management strategies for dental implant procedures.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1- Received Ibuprofen (N=44)

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

Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
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);
Other Names:
  • 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose).
Drug: Acetaminophen 1000 mg
A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
Other Names:
  • A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
Active Comparator: Group 2- Received Dexamethasone (N=44)
This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
Drug: Acetaminophen 1000 mg
A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
Other Names:
  • A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
Drug: Dexamethasone 4 mg
This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
Other Names:
  • 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
Placebo Comparator: Group 3 - Received Placebo (N=44)
This group receives 1 hour before surgery placebo. Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
Drug: Acetaminophen 1000 mg
A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
Other Names:
  • A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
Drug: Placebo
This group receives 1 hour before surgery placebo.
Other Names:
  • Acetaminophen 1000 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain.
Time Frame: 8 hours-time

The Visual Analog Scale (VAS) is a 10-cm line with two extremes at either end: "no pain" (0) and "pain that could not be more severe" (10). Patients were asked to mark a point on the line that best represented their perceived level of pain. The marked position on the line was then measured in centimeters to provide a score between 0 and 10.

  • Minimum Score: 0 (No pain)
  • Maximum Score: 10 (Pain that could not be more severe)
  • Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing greater levels of pain.
  • Unit of Measure: Scores on a scale (0-10)
8 hours-time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain.
Time Frame: 8 hours-time

The Numerical Rating Scale (NRS-101) is a scale ranging from 0 to 100, where 0 represents "no pain" and 10(0) represents either "the worst possible pain" or "the most intense pain imaginable".

  • Minimum Score: 0 (No pain)
  • Maximum Score: 100 (Worst possible pain)
  • Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing higher levels of perceived pain.
  • Unit of Measure: Scores on a scale (0-100)
8 hours-time
The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort.
Time Frame: 8 hours-time

The 4-point Verbal Rating Scale (VRS-4) is a verbal scale used to assess the severity of a given condition, such as pain. Patients rate their experience by selecting one of four verbal descriptors that best represents their perceived intensity, ranging from "no pain" to "severe pain."

  • Minimum Score: 0 (No pain)
  • Maximum Score: 3 (Severe pain)
  • Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived severity. Higher scores indicate worse outcomes, representing greater levels of severity.
  • Unit of Measure: Scores on a scale (0-3)
8 hours-time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Investigators

  • Study Director: Maha Bahammam, Sc, CAGS, EdM, DABP, King Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 1, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimated)

May 5, 2016

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1434/254/287

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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