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| ID | Type | Description | Link |
|---|---|---|---|
| RSRB00058833 | Other Identifier | University of Rochester |
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Study was halted permanently due to enrollment and logistic issues.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenomic Testing | Other | Saliva collection (5mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 hours |
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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 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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastman Institute for Oral Health | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) Pharmacogenomic Testing: Saliva collection (5mL) |
| FG001 | 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) Pharmacogenomic Testing: Saliva collection (5mL) Ibuprofen: 400 mg hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg acetominophen: 650 mg Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) Pharmacogenomic Testing: Saliva collection (5mL) |
| BG001 | Pharmacogenomic Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | subjects completed the study | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
|
6 hours after dosing
any patient reported discomfort that may or may not be related to the medications during the 6 hour observation period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) Pharmacogenomic Testing: Saliva collection (5mL) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yanfang Ren, Professor | University of Rochester Eastman Institute for Oral Health | 5852735588 | yanfang_ren@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2017 | Jan 7, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 16, 2020 | Jan 7, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| C514822 | oxycodone-acetaminophen |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Ibuprofen | Drug | 400 mg |
|
| hydroxycontin/acetominophen | Drug | hydroxycontin 2.5 mg, acetominophen 325 mg |
|
|
| acetominophen | Drug | 650 mg |
|
| Oxycontin/acetominophen | Drug | 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work. |
|
|
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) Pharmacogenomic Testing: Saliva collection (5mL) Ibuprofen: 400 mg hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg acetominophen: 650 mg Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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) Pharmacogenomic Testing: Saliva collection (5mL) Ibuprofen: 400 mg hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg acetominophen: 650 mg Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work. |
|
|
|
| Secondary | 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. | subjects completed the study | Posted | Count of Participants | Participants | 6 hours |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 10 |
| 29 |
| EG001 | 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) Pharmacogenomic Testing: Saliva collection (5mL) Ibuprofen: 400 mg hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg acetominophen: 650 mg Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work. | 0 | 25 | 0 | 25 | 7 | 25 |
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| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |