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

King Abdulaziz University

Status and phase: Completed; Phase 4

Conditions: Pain Measurement

Treatments: Drug: Placebo; Drug: Acetaminophen 1000 mg; Drug: Ibuprofen 600 mg; Drug: Dexamethasone 4 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02763059

1434/254/287

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 3 patient groups, including a placebo group

Group 1- Received Ibuprofen (N=44)

Active Comparator group

Description:

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.

Treatment:

Drug: Ibuprofen 600 mg

Drug: Acetaminophen 1000 mg

Group 2- Received Dexamethasone (N=44)

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone 4 mg

Drug: Acetaminophen 1000 mg

Group 3 - Received Placebo (N=44)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Acetaminophen 1000 mg

Drug: Placebo