Pain Measurement Clinical Trial
— CBDIPPCFSIPOfficial 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
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.
Status | Completed |
Enrollment | 132 |
Est. completion date | February 2016 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
King Abdulaziz University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
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