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Completed

NCT Number: NCT02763059

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

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.

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Key information

Conditions

Pain Measurement

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen 600 mg

Drug

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).

Dexamethasone 4 mg

Drug

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

Drug

This group receives 1 hour before surgery placebo.

Other names: Acetaminophen 1000 mg

Acetaminophen 1000 mg

Drug

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Acronym: CBDIPPCFSIP

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
May 5, 2016
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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