Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes

March 15, 2022 updated by: Yanfang Ren, University of Rochester

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

59

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • Eastman Institute for Oral Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • PGxOne Plus
Drug: Ibuprofen
400 mg
Drug: hydroxycontin/acetominophen
hydroxycontin 2.5 mg, acetominophen 325 mg
Other Names:
  • 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 Names:
  • Percoset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

January 13, 2021

Study Completion (Actual)

January 13, 2021

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UofREDC
  • RSRB00058833 (Other Identifier: University of Rochester)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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