Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft

NCT ID: NCT05919745

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2026-12-31

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.

Conditions

Pain, Post Operative; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Ibuprofen group or Test Group

Subjects will be given ibuprofen 600mg tab 1h prior to surgery.

Group Type: EXPERIMENTAL

Ibuprofen 600 mg

Intervention Type: DRUG

Preoperative delivery of ibuprofen per os.

Acetaminophen

Intervention Type: DRUG

Both 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.

Placebo group or Control group

Subjects will be given a placebo tab 1h prior to surgery.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Preoperative delivery of placebo per os.

Acetaminophen

Intervention Type: DRUG

Both 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.

Interventions

Ibuprofen 600 mg

Preoperative delivery of ibuprofen per os.

Intervention Type: DRUG

Placebo

Preoperative delivery of placebo per os.

Intervention Type: DRUG

Acetaminophen

Both 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.

Intervention Type: DRUG

Other Intervention Names

Test; Control; Rescue medication

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marquette University

OTHER

Sponsor Role: lead

Responsible Party

Vrisiis Kofina

Director, Advanced Education in Periodontics Program, Assistant Professor of Periodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vrisiis Kofina, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

Marquette University

Locations

Marquette University School of Dentistry Graduate Periodontics Clinic

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vrisiis Kofina, DDS, MS

Role: CONTACT

vrisiis.kofina@marquette.edu

516-817-0393

Christos Gousias, DDS

Role: CONTACT

christos.gousias@marquette.edu

414-229-8875

Facility Contacts

Vrisiis Kofina, DDS, MS

Role: primary

vrisiis.kofina@marquette.edu

4142886521

Arndt Guentsch, DMD, PhD, MHBA, MS

Role: backup

arndt.guentsch@marquette.edu

4142886089

Other Identifiers

HR-4154

Identifier Type: -

Identifier Source: org_study_id