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Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes

Primary Purpose

Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pharmacogenomic Testing
Ibuprofen
hydroxycontin/acetominophen
acetominophen
Oxycontin/acetominophen
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Eastman Institute for Oral Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Pharmacogenomic Group

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants That Did Not Need Opioid Analgesic Prescriptions
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.

Full Information

First Posted
September 29, 2016
Last Updated
March 15, 2022
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT02932579
Brief Title
Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes
Official Title
Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Study was halted permanently due to enrollment and logistic issues.
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
January 13, 2021 (Actual)
Study Completion Date
January 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Arm Title
Pharmacogenomic Group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Pharmacogenomic Testing
Other Intervention Name(s)
PGxOne Plus
Intervention Description
Saliva collection (5mL)
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
400 mg
Intervention Type
Drug
Intervention Name(s)
hydroxycontin/acetominophen
Other Intervention Name(s)
Norco
Intervention Description
hydroxycontin 2.5 mg, acetominophen 325 mg
Intervention Type
Drug
Intervention Name(s)
acetominophen
Intervention Description
650 mg
Intervention Type
Drug
Intervention Name(s)
Oxycontin/acetominophen
Other Intervention Name(s)
Percoset
Intervention Description
5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.
Primary Outcome Measure Information:
Title
Mean Pain Score
Description
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.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Number of Participants That Did Not Need Opioid Analgesic Prescriptions
Description
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.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Eastman Institute for Oral Health
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes

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