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

NCT02763059 | Completed Phase 4 Results DMC

• 1 other identifier: 1434/254/287
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
2. 2.4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or
3. 3.placebo.

Conditions

Pain Measurement

Outcome Measures

Primary Outcomes (1)

• The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain.

  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 Outcomes (2)

• the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain.

  8 hours-time

• The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort.

  8 hours-time

Study Arms (3)

Group 1- Received Ibuprofen (N=44)

ACTIVE COMPARATOR

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; Drug: Acetaminophen 1000 mg

Group 2- Received Dexamethasone (N=44)

ACTIVE COMPARATOR

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: Dexamethasone 4 mg; Drug: Acetaminophen 1000 mg

Group 3 - Received Placebo (N=44)

PLACEBO COMPARATOR

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: Placebo; Drug: Acetaminophen 1000 mg

Interventions

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);

Also known as: 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose).

Group 1- Received Ibuprofen (N=44)

Dexamethasone 4 mg DRUG

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

Also known as: 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)

Group 2- Received Dexamethasone (N=44)

Placebo DRUG

This group receives 1 hour before surgery placebo.

Also known as: Acetaminophen 1000 mg

Group 3 - Received Placebo (N=44)

Acetaminophen 1000 mg DRUG

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

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

Group 1- Received Ibuprofen (N=44); Group 2- Received Dexamethasone (N=44); Group 3 - Received Placebo (N=44)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent for the described procedure
• Surgical placement of a single endosteal implant
• Age of at least 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdulaziz University: lead

Related Publications (1)

• Bahammam MA, Kayal RA, Alasmari DS, Attia MS, Bahammam LA, Hassan MH, Alzoman HA, Almas K, Steffens JP. Comparison Between Dexamethasone and Ibuprofen for Postoperative Pain Prevention and Control After Surgical Implant Placement: A Double-Masked, Parallel-Group, Placebo-Controlled Randomized Clinical Trial. J Periodontol. 2017 Jan;88(1):69-77. doi: 10.1902/jop.2016.160353. Epub 2016 Aug 26.

  PMID: 27562219 DERIVED

MeSH Terms

Interventions

Ibuprofen; Dexamethasone; Acetaminophen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Prof. Maha A Bahammam
• Organization: King Abdulaziz University

mbahammam@kau.edu.sa

00966126400000

Study Officials

• Maha Bahammam, Sc, CAGS, EdM, DABP

  King Abdulaziz University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Consultant of Periodontology

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: May 5, 2016
• Study Start: September 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: February 1, 2016
• Last Updated: November 13, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-10