NCT06275191

Alternatives to Dental Opioid Prescribing After Tooth Extraction

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 38,159 (estimated)
• Sponsor: Douglas Oyler · Academic / Other
• Sex: All
• Age: 12 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are: * Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal? * Do oral surgeons' beliefs about the intervention and opioid prescribing change? * Do patients that report using opioids after tooth removal have different experiences than patients that do not? Oral surgeon participants will: * Attend a 1-hour education session with a trained pharmacist * Receive patient instructions and blister packs of pain medicine to give to patients * Complete 2 surveys about feasibility and appropriateness Patient participants will complete a survey about pain and medication use after having a tooth removed. Researchers will compare the intervention to usual care to see if it reduces opioid prescribing.

Detailed description

Although use of nonsteroidal antiinflammatory drugs and acetaminophen is recommended first-line by the American Dental Association and American Association of Oral and Maxillofacial Surgeons, dentists and oral surgeons are leading prescribers of opioids to adolescents and young adults (AYA), who are at high risk for developing problematic opioid use after an initial exposure. This multi-site, stepped wedge cluster-randomized trial will assess whether a multicomponent behavioral intervention can influence opioid prescribing behavior among dentists and oral surgeons compared to usual practice. Across up to 12 clinical practices (clusters), up to 33 dentists and oral surgeons (provider participants) who perform tooth extractions for individuals 12-25 years old will be enrolled. After enrollment, all provider participants will receive the intervention at a time based on the sequence to which their cluster is randomized. The intervention consists of academic detailing plus provision of standardized patient post-extraction instructions and blister packs of acetaminophen (APAP) and ibuprofen for dispensing. Provider participants will dispense the blister packs and distribute the patient instructions at their discretion to AYA undergoing tooth extraction, with or without additional analgesics (e.g., opioids). The primary outcome is a binary, patient-level indicator of electronic post-extraction opioid prescription. Data for the primary outcome will be collected from the provider participant's electronic health records quarterly throughout the study. Provider participants will complete a survey before and approximately 3 months after transitioning into the intervention condition to assess implementation outcomes. AYA patients undergoing tooth extraction will be offered a survey to assess pain control and satisfaction with pain management in the week after their extraction. Primary analyses will use generalized estimating equations to compare the binary patient-level indicator of being prescribed a post-extraction opioid in the intervention condition compared to the control condition (i.e., usual practice). Analyses will adjust for patient-level factors (e.g., sex, number of teeth extracted, etc.). Secondary analyses will assess provider participants' perceptions of feasibility and appropriateness of the intervention, and patient-reported pain control and satisfaction with pain management.

Conditions

• Analgesics, Opioid
• Acute Pain
• Tooth Extraction
• Adolescent
• Acetaminophen
• Ibuprofen

Interventions

Type	Name	Description
BEHAVIORAL	Multicomponent intervention	The multicomponent intervention consists of (1) a single 45-60-minute academic detailing session with provider participants, plus (2) provision of patient post-extraction instruction materials and (3) provision of blister-packaged acetaminophen and ibuprofen for distribution to adolescent/young adult patients after tooth extraction in the course of clinical practice
OTHER	Usual care	No intervention.

Timeline

• Start date: 2024-04-16
• Primary completion: 2028-01-01
• Completion: 2028-12-01
• First posted: 2024-02-23
• Last updated: 2025-06-25

Locations

1 site across 1 country: United States