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

NCT ID: NCT02763059

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-02-29

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. 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.

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.

Conditions

Pain Measurement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ibuprofen 600 mg

Intervention Type: DRUG

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

Acetaminophen 1000 mg

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone 4 mg

Intervention Type: DRUG

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

Acetaminophen 1000 mg

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

This group receives 1 hour before surgery placebo.

Acetaminophen 1000 mg

Intervention Type: DRUG

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

Interventions

Ibuprofen 600 mg

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

Intervention Type: DRUG

Dexamethasone 4 mg

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

Intervention Type: DRUG

Placebo

This group receives 1 hour before surgery placebo.

Intervention Type: DRUG

Acetaminophen 1000 mg

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

Intervention Type: DRUG

Other Intervention Names

600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose).; 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Maha A. Bahammam

Associate Professor and Consultant of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha Bahammam, Sc, CAGS, EdM, DABP

Role: STUDY_DIRECTOR

King Abdulaziz University

References

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.

Reference Type: DERIVED

PMID: 27562219 (View on PubMed)

Other Identifiers

1434/254/287

Identifier Type: -

Identifier Source: org_study_id