Pain, Post OperativePhase 4NCT05919745
Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft
A Phase 4 study testing Ibuprofen 600 mg and Acetaminophen in people with Pain, Post Operative and Quality of Life, run by Marquette University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Post Operative, Quality of Life
- What is being tested?
- Ibuprofen 600 mg and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2023to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- Good general health (controlled conditions)
- Fluent in English
- Treatment-planned for single site extraction and bone graft surgery
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Marquette University School of Dentistry Graduate Periodontics Clinic
Milwaukee, Wisconsin, 53233
Vrisiis Kofina, DDS, MS, 4142886521, vrisiis.kofina@marquette.edu
Arndt Guentsch, DMD, PhD, MHBA, MS, 4142886089, arndt.guentsch@marquette.edu
About this study
Official title: Patient Perception of Pain Following Extraction and Bone Graft Surgery With or Without Preemptive Ibuprofen: A Randomized Clinical 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:
Read more
- 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?
Read the 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
- Being tested
- Ibuprofen 600 mg, Placebo, Acetaminophen
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 600 mgDrug
Also called Test
Preoperative delivery of ibuprofen per os.
PlaceboDrug
Also called Control
Preoperative delivery of placebo per os.
AcetaminophenDrug
Also called Rescue medication
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.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen group or Test Group | Experimental | Subjects will be given ibuprofen 600mg tab 1h prior to surgery. Receives: Drug: Ibuprofen 600 mg; Drug: Acetaminophen |
| Placebo group or Control group | Placebo comparator | Subjects will be given a placebo tab 1h prior to surgery. Receives: Drug: Placebo; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour following extraction and bone graft surgery
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: Postoperative days 2, 5 and 7 following extraction and bone graft surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start19 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Post OperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vrisiis Kofina, Marquette University
- Investigators
- Vrisiis Kofina, DDS, MS, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919745
- Sponsor's protocol ID
- HR-4154
- Status last verified
- Sep 2024
- First submitted
- 9 Jun 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perception of Pain Following Extraction and Bone Graft Surgery With or Without Preemptive Ibuprofen: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05919745
- Acronym / sponsor ID
- HR-4154
- Conditions
- Pain, Post Operative, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen group or Test Group | Experimental | Drug: Ibuprofen 600 mg, Drug: AcetaminophenSubjects will be given ibuprofen 600mg tab 1h prior to surgery. |
| Placebo group or Control group | Placebo comparator | Drug: Placebo, Drug: AcetaminophenSubjects will be given a placebo tab 1h prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Good general health (controlled conditions)
- Fluent in English
- Treatment-planned for single site extraction and bone graft surgery
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 600 mgAlso: TestPreoperative delivery of ibuprofen per os. | Drug | Ibuprofen group or Test Group |
| PlaceboAlso: ControlPreoperative delivery of placebo per os. | Drug | Placebo group or Control group |
| AcetaminophenAlso: Rescue medicationBoth 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. | Drug | Ibuprofen group or Test Group, Placebo group or Control group |
Primary outcome
Difference in patient-reported postoperative pain between test and control group
Time frame: 1 hour following extraction and bone graft surgery
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.
2 secondary outcomes
Difference in patient-reported postoperative pain between test and control group
Time frame: 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
Time frame: Postoperative days 2, 5 and 7 following extraction and bone graft surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vrisiis Kofina, DDS, MS principal investigator
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen 600 mg and Acetaminophen in people with Pain, Post Operative and Quality of Life, run by Marquette University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vrisiis Kofina, DDS, MS (516-817-0393, vrisiis.kofina@marquette.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in patient-reported postoperative pain between test and control group (time frame: 1 hour following extraction and bone graft surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.