Clinical trial NCT05919745: Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft
Official title: Patient Perception of Pain Following Extraction and Bone Graft Surgery With or Without Preemptive Ibuprofen: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Post Operative
Quality of Life
Lead sponsor: Marquette University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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?

Detailed description: The null hypothesis of this randomized clinical trial is that there is no difference in patient-reported pain and oral health-related quality of life during the first postoperative week following extraction and bone graft surgery between patients who received 600mg of preemptive ibuprofen versus placebo.

Participants will receive ibuprofen 600mg (test group) or placebo (control group) per os 1 hour prior to extraction and bone graft surgery. Researchers and patients will be blinded to the group assignment. Both groups will be given rescue medication in the form of 1,000 mg tabs of acetaminophen every 6 hours 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.

Patient-reported pain will be collected by Visual Analogue Scale (VAS) before surgery, every hour for the first 3 postoperative hours and on postoperative days 1-7. VAS for patient-reported swelling will also be recorded at the same time points. Number of rescue medications will be recorded at the same postoperative time points. Oral health-related quality of life as expressed by Oral Health Impact Profile-14 (OHIP-14) questionnaire will be reported before surgery and on postoperative days 2, 5 and 7. Questionnaires on dental anxiety (Modified Dental Anxiety Scale), oral health literacy (Rapid estimate of Adult Literacy in Dentistry 30 Short Form), fear of pain (Fear of pain questionnaire-9) and pain catastrophizing (Pain catastrophizing scale) will be collected prior to surgery and will be evaluated as pain modifiers. Anticipated pain will be reported prior to surgery and questions on comparison between actual and anticipated pain and willingness to undergo a similar procedure again will be asked on days 1 and 7. Surgical and demographic data as well as medical history will be collected on the day of surgery. Clinical wound healing observations will be recorded on day 7.

Eligibility criteria: Inclusion Criteria

* Age \>18 years
* Good general health (controlled conditions)
* Fluent in English
* Treatment-planned for single site extraction and bone graft surgery

Exclusion criteria

* 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
* Patients receiving surgery under sedation
* Patients with any contraindication for oral bone grafting surgery (e.g., on anticoagulants, medication-related osteonecrosis of the jaw, etc.)
* Patients experiencing acute or chronic oral pain due to conditions or previous interventions
* Patients with diseases or taking medications that affect hard and soft tissue wound healing such as poorly controlled diabetes, bisphosphonate use, corticosteroid use, chemotherapy, immunosuppressive therapy, etc.
* Current or chronic (≥4 weeks) use of anti-inflammatory, analgesic, corticosteroid or sedative medications in the past 6 months
* Health conditions that contraindicate the use of NSAIDs, such as stomach ulcers, bleeding disorders, renal disfunction, liver cirrhosis or acute liver disease, etc.
* Intake of medications that interact with NSAIDs or whose actions can be affected by NSAIDs, such as anticoagulant/antiplatelet medications, ACE inhibitors, diuretics, etc.
* Allergy to ibuprofen, acetaminophen and/or aspirin, and study materials (e.g., sutures, grafts, membranes?).
* Patients having 3 or more alcoholic beverages daily
* Patients who are planned to undergo heart surgery or had heart surgery less than 6 months prior
* Not fluent in English

Primary outcomes:
measure: Difference in patient-reported postoperative pain between test and control group
timeFrame: 1 hour following extraction and bone graft surgery
Secondary outcomes:
measure: Difference in patient-reported postoperative pain between test and control group
timeFrame: Postoperative hours 2 and 3, and postoperative days 1, 2, 3, 4, 5, 6 and 7 following extraction and bone graft surgery.
measure: Difference in Oral Health Impact Profile-14 between test and control group
timeFrame: Postoperative days 2, 5 and 7 following extraction and bone graft surgery
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University School of Dentistry Graduate Periodontics Clinic
state: Wisconsin
Study officials:
affiliation: Marquette University
name: Vrisiis Kofina, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: