Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarquette University
About this trial
The goal of this randomized clinical trial is to compare patient-reported pain and oral health-related quality of life during the first postoperative week following extraction and bone graft surgery in patients who received preemptive ibuprofen versus placebo. Participants will receive ibuprofen 600mg or placebo by mouth with water 1 hour prior to extraction and bone graft surgery.
The primary question it aims to answer is:
• Does preemptive ibuprofen have an effect on postoperative pain 1 hour following extraction and bone graft surgery compared to placebo?
Secondary questions are:
* Does preemptive ibuprofen have an effect on pain during the first 3 postoperative hours and 7 postoperative days following extraction and bone graft surgery compared to placebo? * Does preemptive ibuprofen have an effect on oral health-related quality of life during the 7 postoperative days following extraction and bone graft surgery compared to placebo?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >18 years
Good general health (controlled conditions)
Fluent in English
Treatment-planned for single site extraction and bone graft surgery
Disqualifiers
Pregnancy
Site with active infection i.e purulence, abscess formation
Patients experiencing pain pre-operatively
Oral surgery in more than one site/quadrant in the same session
Trial design
Design model
Parallel
Treatments tested in this trial
Ibuprofen 600 mg
DrugPreoperative delivery of ibuprofen per os.
Placebo
DrugPreoperative delivery of placebo per os.
Acetaminophen
DrugBoth groups will be given rescue medication in the form of 1,000 mg tabs of acetaminophen every 6 hours per os as needed for pain (maximum allowed daily dose 4,000 mg per FDA) and will be allowed to receive ibuprofen or other analgesic medication as needed if pain is not controlled by acetaminophen alone. The subjects will receive the rescue medication pills at the end of the surgical appointment.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Ibuprofen group or Test GroupExperimental treatment 2 interventions
Group B: Placebo group or Control groupPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Difference in patient-reported postoperative pain between test and control group
Visual Analogue Scale will be used to measure patient-reported pain. Its score range from 0-100 and the higher the score, the worse the reported pain is. Specifically, zero represents no pain and 100 represents the worst pain imaginable.
Time frame
1 hour following extraction and bone graft surgerySecondary outcomes
1
Difference in patient-reported postoperative pain between test and control group
Visual Analogue Scale will be used to measure patient-reported pain. Its score range from 0-100 and the higher the score, the worse the reported pain is. Specifically, zero represents no pain and 100 represents the worst pain imaginable.
Time frame
Postoperative hours 2 and 3, and postoperative days 1, 2, 3, 4, 5, 6 and 7 following extraction and bone graft surgery.2
Difference in Oral Health Impact Profile-14 between test and control group
Oral Health Impact Profile-14 is a validated widely used questionnaire that reliably measures oral health-related quality of life by recording patient perception of the impact of oral conditions on their well-being. Specifically, it consists of seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Its scores range from 0-56 and the higher the total score, the more impacted, i.e., worse, the quality of life is.
Time frame
Postoperative days 2, 5 and 7 following extraction and bone graft surgerySponsors and contacts
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Source ClinicalTrials.gov