NCT02932579

Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	Pharmacogenomic Testing	Saliva collection (5mL)
DRUG	Ibuprofen	400 mg
DRUG	hydroxycontin/acetominophen	hydroxycontin 2.5 mg, acetominophen 325 mg
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.

Timeline

• Start date: 2017-07-01
• Primary completion: 2021-01-13
• Completion: 2021-01-13
• First posted: 2016-10-13
• Last updated: 2022-03-16
• Results posted: 2022-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study