Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes

NCT02932579 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: UofREDCRSRB00058833
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Mean Pain Score

  To compare the pain control outcomes between a single-dose of pharmacogenomics- testing-driven-prescription of ibuprofen (400mg) or acetaminophen (650mg) with those of single-dose (standard of care) of combined formulation of hydrocodone and acetaminophen (5/650mg). A visual analog scale for dental pain will be used. Scale ranges from 0-100 with 100 worse pain.

  6 hours

Secondary Outcomes (1)

• Number of Participants That Did Not Need Opioid Analgesic Prescriptions

  6 hours

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Other: Pharmacogenomic Testing

Pharmacogenomic Group

EXPERIMENTAL

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)

Other: Pharmacogenomic Testing; Drug: Ibuprofen; Drug: hydroxycontin/acetominophen; Drug: acetominophen; Drug: Oxycontin/acetominophen

Interventions

Pharmacogenomic Testing OTHER

Saliva collection (5mL)

Also known as: PGxOne Plus

Pharmacogenomic Group; Standard of Care

Ibuprofen DRUG

400 mg

Pharmacogenomic Group

hydroxycontin/acetominophen DRUG

hydroxycontin 2.5 mg, acetominophen 325 mg

Also known as: Norco

Pharmacogenomic Group

acetominophen DRUG

650 mg

Pharmacogenomic Group

Oxycontin/acetominophen DRUG

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

Also known as: Percoset

Pharmacogenomic Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Eastman Institute for Oral Health

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Pharmacogenomic Testing; Ibuprofen; Acetaminophen; oxycodone-acetaminophen; Oxycodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Yanfang Ren, Professor
• Organization: University of Rochester Eastman Institute for Oral Health

yanfang_ren@urmc.rochester.edu

5852735588

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 13, 2016
• Study Start: July 1, 2017
• Primary Completion: January 13, 2021
• Study Completion: January 13, 2021
• Last Updated: March 16, 2022
• Results First Posted: March 16, 2022

Record last verified: 2022-03

Locations

US (1)