Clinical trial NCT02763059: Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Measurement
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The visual analog scale (VAS) was used to measures levels of pain.
timeFrame: 8 hours-time
Secondary outcomes:
measure: the 101-point numerical rate scale (NRS-101) was used to measures levels of pain.
timeFrame: 8 hours-time
measure: The 4-point verbal rating scale (VRS-4) was used to measures levels of discomfort.
timeFrame: 8 hours-time
Other outcomes:
Locations:
Study officials:
References:
citation: 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.