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

Study Overview
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Brief Summary
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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: 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) or 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.

Official Title
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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

Conditions
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Pain Measurement

Intervention / Treatment
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* Drug: Ibuprofen 600 mg
* Drug: Dexamethasone 4 mg
* Drug: Placebo
* Drug: Acetaminophen 1000 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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