Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft

NCT05919745 | Recruiting Phase 4

• 1 other identifier: HR-4154
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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?

Conditions

Pain, Post Operative; Quality of Life

Outcome Measures

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.

  1 hour following extraction and bone graft surgery

Secondary Outcomes (2)

• Difference in patient-reported postoperative pain between test and control group

  Postoperative hours 2 and 3, and postoperative days 1, 2, 3, 4, 5, 6 and 7 following extraction and bone graft surgery.

• Difference in Oral Health Impact Profile-14 between test and control group

  Postoperative days 2, 5 and 7 following extraction and bone graft surgery

Study Arms (2)

Ibuprofen group or Test Group

EXPERIMENTAL

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

Drug: Ibuprofen 600 mg; Drug: Acetaminophen

Placebo group or Control group

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Acetaminophen

Interventions

Ibuprofen 600 mg DRUG

Preoperative delivery of ibuprofen per os.

Also known as: Test

Ibuprofen group or Test Group

Placebo DRUG

Preoperative delivery of placebo per os.

Also known as: Control

Placebo group or Control group

Acetaminophen 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.

Also known as: Rescue medication

Ibuprofen group or Test Group; Placebo group or Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marquette University: lead

Study Sites (1)

Marquette University School of Dentistry Graduate Periodontics Clinic

Milwaukee, Wisconsin, 53233, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Vrisiis Kofina, DDS, MS

  Marquette University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vrisiis Kofina, DDS, MS

CONTACT

516-817-0393; vrisiis.kofina@marquette.edu

Christos Gousias, DDS

CONTACT

414-229-8875; christos.gousias@marquette.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Advanced Education in Periodontics Program, Assistant Professor of Periodontics

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 26, 2023
• Study Start: October 19, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)