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Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes

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ClinicalTrials.gov Identifier: NCT02932579
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Yanfang Ren, University of Rochester

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.


Condition or disease Intervention/treatment Phase
Pain Other: Pharmacogenomic Testing Drug: Ibuprofen Drug: hydroxycontin/acetominophen Drug: acetominophen Drug: Oxycontin/acetominophen Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Active Comparator: 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)
Other: Pharmacogenomic Testing
Saliva collection (5mL)
Other Name: PGxOne Plus

Experimental: 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)
Other: Pharmacogenomic Testing
Saliva collection (5mL)
Other Name: PGxOne Plus

Drug: Ibuprofen
400 mg

Drug: hydroxycontin/acetominophen
hydroxycontin 2.5 mg, acetominophen 325 mg
Other Name: Norco

Drug: acetominophen
650 mg

Drug: Oxycontin/acetominophen
5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.
Other Name: Percoset




Primary Outcome Measures :
  1. Mean pain score [ Time Frame: 6 hours ]
    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.


Secondary Outcome Measures :
  1. Number of participants that did not need Opioid Analgesic Prescriptions [ Time Frame: 6 hours ]
    To determine the number of patients who did not require prescribed opioid analgesic'rescue' after pharmacogenomic-guided acute postoperative dental pain management versus those taking the non-guided combined formulation of hydrocodone and acetaminophen.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932579


Contacts
Contact: Rita Cacciato, RDH, BS 585-275-9001 rita_cacciato@URMC.rochester.edu

Locations
United States, New York
Eastman Institute for Oral Health Recruiting
Rochester, New York, United States, 14642
Contact: Stacie Ellis    585-273-4489    Stacie_Ellis@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester

Responsible Party: Yanfang Ren, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02932579     History of Changes
Other Study ID Numbers: UofREDC
RSRB00058833 ( Other Identifier: University of Rochester )
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ibuprofen
Acetaminophen
Oxycodone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antipyretics