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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: King Abdulaziz University
• Treatments: Acetaminophen; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ibuprofen

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