Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes

NCT ID: NCT02932579

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2021-01-13

Brief Summary

Opioid analgesics are the most common postoperative pain medications used among dentists in the United States.Although these medications are highly effective in the postoperative dental pain management, not all patients optimally benefit from this therapy. Many suffer adverse consequences such as nausea, emesis, and psychomotor impairment, and there is a high prevalence of opioid prescription misuse among substance abusers within the dental patient population.

The use of non-opioid analgesics including ibuprofen and acetaminophen in the management of postoperative dental pain has demonstrated equivalent or superior analgesic effects compared to opioid analgesic therapies, typically with significantly less adverse effects.However, despite these results, dentists have encountered a high variability in the success of non-opioid analgesic responses among the postoperative dental pain population.Thus, new strategies for earlier recognition of analgesic responses for pain medications is fundamental in the field of dentistry. Therefore, this study will evaluate the clinical utility of pharmacogenomic testing in acute postoperative dental pain management among healthy adults who undergo extraction of impacted mandibular third molar.

Detailed Description

To date, the use of pharmacogenomic methods in medicine has broadened our understanding of the important role of genes and different phenotypes/genotypes that make each individual unique in pain responses, including drug biotransformation, transportation, and drug-related side effects to name a few.Thus, recognizing the genetic profile of each individual prior to the prescription of pain medication for postoperative dental pain management will be essential to provide a more effective and safer pain therapy.Additionally, we suggest that 80% of the individuals in the general population exhibit a genetic profile that influence a normal pain response to non-opioid pain therapies. Hence we postulate that the integration of a pharmacogenomic testing to guide the prescription of ibuprofen and acetaminophen, not only, could lead to improved clinical postoperative dental pain outcomes, but also, significantly reduce opioid analgesics prescriptions by dentists.

Conditions

Pain

Study Design

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

Study Groups

Standard of Care

Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)

Group Type: ACTIVE_COMPARATOR

Pharmacogenomic Testing

Intervention Type: OTHER

Saliva collection (5mL)

Pharmacogenomic Group

Individuals within this group will receive pharmacogenomic testing guided prescription of pain medication for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)

Group Type: EXPERIMENTAL

Pharmacogenomic Testing

Intervention Type: OTHER

Saliva collection (5mL)

Ibuprofen

Intervention Type: DRUG

400 mg

hydroxycontin/acetominophen

Intervention Type: DRUG

hydroxycontin 2.5 mg, acetominophen 325 mg

acetominophen

Intervention Type: DRUG

650 mg

Oxycontin/acetominophen

Intervention Type: DRUG

5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.

Interventions

Pharmacogenomic Testing

Saliva collection (5mL)

Intervention Type: OTHER

Ibuprofen

400 mg

Intervention Type: DRUG

hydroxycontin/acetominophen

hydroxycontin 2.5 mg, acetominophen 325 mg

Intervention Type: DRUG

acetominophen

650 mg

Intervention Type: DRUG

Oxycontin/acetominophen

5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.

Intervention Type: DRUG

Other Intervention Names

PGxOne Plus; Norco; Percoset

Eligibility Criteria

Inclusion Criteria

• Patients who are able to read, comprehend, and sign the consent form, and willing to stay in the study unit for up to 12 hours.
• Patients who are reliable, cooperative, and of adequate intelligence to record the requested information on the questionnaire form(s).
• Women of childbearing potential who are not pregnant, as assessed by a urine pregnancy quick test on the day of the procedure, prior to surgery. Women must be using a method of birth control deemed acceptable by the investigator and continue to use this method during the duration of dosing with study medication
• Patient who develop sufficient levels of pain (rated at 50mm or more out of a 100 mm) on the DPIS within 6 hours post-surgical extraction.
• Patients who agree not to take analgesics other than protocol-defined rescue analgesics during the post-operative treatment period of 6 hours.

• Patients who agree to refrain from alcohol and sedative consumption during the post-operative period of 6 hours.
• Patients scheduled to undergo surgical removal of 3 or more impacted third molars, at least 1 of which must be a bony mandibular impaction. In addition, the sum of the dental impaction scores must be 9 or above, carried out by investigator.

Exclusion Criteria

Subjects with:

• Known opioids and NSAIDs allergies (or induced asthmatic attacks)
• Known history of opioid abuse
• Recent history of gastrointestinal ulceration
• History of aspirin intolerance/cross-sensitivity
• Recent myocardial disease
• Uncontrolled hypertension
• Patients receiving anticoagulation therapy
• Uncontrolled diabetes
• Pregnant women
• Immunosuppression
• Recent history of opioid or NSAID therapies
• Subjects who do not achieve a qualifying baseline pain threshold of 50mm out of 100mm on the visual analog DIPS within 6 hours of completion of surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Yanfang Ren

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eastman Institute for Oral Health

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RSRB00058833

Identifier Type: OTHER

Identifier Source: secondary_id

UofREDC

Identifier Type: -

Identifier Source: org_study_id