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

Phase 4

Completed

• Conditions: Pain Measurement
• Interventions: Drug: Ibuprofen 600 mg; Drug: Dexamethasone 4 mg; Drug: Placebo; Drug: Acetaminophen 1000 mg

• Registration Number: NCT02763059
• Lead Sponsor: King Abdulaziz University

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

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2015-05
• Study Completion: 2016-02
• Status Verified: 2016-05
• Study First Submitted: 2016-05-01
• Study First Submitted QC: 2016-05-04
• Last Update Submitted: 2016-05-04
• Study First Posted: 2016-05-05
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1- Received Ibuprofen (N=44)	Ibuprofen 600 mg	-
Group 2- Received Dexamethasone (N=44)	Dexamethasone 4 mg	-
Group 2- Received Dexamethasone (N=44)	Acetaminophen 1000 mg	-
Group 1- Received Ibuprofen (N=44)	Acetaminophen 1000 mg	-
Group 3 - Received Placebo (N=44)	Placebo	-
Group 3 - Received Placebo (N=44)	Acetaminophen 1000 mg	-

Primary Outcome Measures

Name	Time	Method
The visual analog scale (VAS) was used to measures levels of pain.	8 hours-time	a visual analog scale (VAS) consisting of a 10-cm line with two extremes at either end; "no pain" and "pain that could not be more severe". Patients were asked to mark a point on the line that represented their level of perceived pain.

Secondary Outcome Measures

Name	Time	Method
The 4-point verbal rating scale (VRS-4) was used to measures levels of discomfort.	8 hours-time	the patient specifies one of four options: no discomfort, some discomfort, considerable discomfort, or discomfort that could not be more severe.
the 101-point numerical rate scale (NRS-101) was used to measures levels of pain.	8 hours-time	the patients were asked to rate their pain intensity on a numeric scale ranging from 0 to 100.