Alternatives to Dental Opioid Prescribing After Tooth Extraction (ADOPT)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Adolescent; Acute Pain; Tooth Extraction; Acetaminophen; Analgesics, Opioid; Ibuprofen
• Intervention / Treatment: Behavioral: Multicomponent intervention; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Estimated): 38159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (Provider):

• Actively U.S. licensed dentist or oral surgeon practicing at a participating cluster. Participating clinics were finalized prior to the beginning of the study based on the following criteria: (1) perform tooth extractions on at least 70 AYA patients during a 5-month screening period from July 1, 2022 through November 30, 2022 and (2) electronically prescribe opioids to at least 30% of AYA patients who underwent extraction during the screening period. Additionally, each participating cluster signed a data use agreement (DUA) for sharing electronic health record data, can provide the necessary electronic health record data, and agreed to comply with study procedures and be available for the duration of the study.
• Provide a signed and dated informed consent form.
• Willing to comply with all study procedures and be available for the duration of the study.

Inclusion Criteria (Patient):

• Undergoes any tooth extraction at a participating cluster during the study (intervention condition, transition period, or control condition) between 6-10 days earlier.
• Age 12-25 at the time of tooth extraction.
• Reads and acknowledges survey cover letter in lieu of a full consent/assent process.
• Can access the electronic survey using an internet-capable device.

Exclusion Criteria:

• There are no other exclusion criteria for clusters or provider/patient participants that meet all inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention condition; Academic detailing (45 to 60-minute session), plus; Provision of standardized patient post-extraction instructions for distribution, plus; Provision of blister-packaged acetaminophen and ibuprofen at recommended standard doses for distribution to to adolescent/young adult patients after tooth extraction in the course of clinical practice	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
Active Comparator: Control condition; Usual practice	Other: Usual care; No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction	The primary outcome is a patient-level binary indicator for being prescribed an opioid. The value for this outcome variable is equal to 1 if the patient is prescribed an opioid, whereas this variable takes on a value of 0 if this patient is not prescribed an opioid. Opioid prescription will be defined as an electronic order (from the electronic health record) for an opioid analgesic (e.g., hydrocodone, oxycodone, tramadol, morphine, fentanyl, etc.) on the same calendar date as the tooth extraction appointment.	Same calendar date as dental extraction. Electronic health records will be extracted for the duration of the 4-year study period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Change in) intervention feasibility	Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding feasibility of distributing blister packs and patient post-extraction materials. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.	Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
(Change in) intervention appropriateness	Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding appropriateness of distributing blister packs and patient post-extraction materials. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.	Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
(Change in) opioid prescribing feasibility	Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding feasibility of reducing opioid prescription. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.	Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
(Change in) opioid prescribing appropriateness	Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding appropriateness of reducing opioid prescription. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.	Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
Self-reported pain	Patient survey, 3 items from Brief Pain Inventory (worst, least, average pain) based on self-reported opioid use. Each item uses an 11-point Visual Rating Scale from 0-no pain to 10-worst possible pain.	within 10 days of tooth extraction
Self-reported pain interference	Patient survey, NIH PROMIS Pediatric Short Form v1.0-Pain Interference 8a (age < 18) or NIH PROMIS Adult Short Form v1.0-Pain Interference 6b (18+) based on self-reported opioid use. NIH PROMIS Pediatric Short Form t-scores range from 34.0 to 78.0, with higher scores indicating greater interference. NIH PROMIS Adult Short Form t scores range from 41.0 to 78.3, with higher scores indicating greater interference.	within 10 days of tooth extraction
Self-reported pain satisfaction	Patient survey, 5-point Likert-type question (from 1-very unhappy to 5-very happy) regarding overall satisfaction with pain management based on self-reported opioid use. Selection of the top 2 choices (very happy or happy) from the scale is considered as satisfaction with overall pain management.	within 10 days of tooth extraction

Collaborators and Investigators

• Sponsor: Douglas Oyler
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Douglas R Oyler, PharmD, University of Kentucky; Principal Investigator: Marcia V Rojas Ramirez, DDS, University of Kentucky

Publications and helpful links

General Publications

• Oyler DR, Rojas-Ramirez MV, Nakamura A, Quesinberry D, Miller CS. Dental opioid prescription patterns in academic and community settings. J Public Health Dent. 2023 Jun;83(2):200-206. doi: 10.1111/jphd.12568. Epub 2023 Mar 11.
• Oyler DR, Rojas-Ramirez MV, Nakamura A, Quesinberry D, Bernard P, Surratt H, Miller CS. Factors influencing opioid prescribing after tooth extraction. J Am Dent Assoc. 2022 Sep;153(9):868-877. doi: 10.1016/j.adaj.2022.05.001. Epub 2022 Jun 9.
• Oyler DR, Miller CS. Patterns of opioid prescribing in an Appalachian college of dentistry. J Am Dent Assoc. 2021 Mar;152(3):209-214. doi: 10.1016/j.adaj.2020.12.002.
• Oyler DR, Westgate PM, Walsh SL, Dolly Prothro J, Miller CS, Roberts MF, Freeman PR, Knudsen HK, Lang M, Dominguez-Fernandez E, Rojas-Ramirez MV. Alternatives to dental opioid prescribing after tooth extraction (ADOPT): protocol for a stepped wedge cluster randomized trial. BMC Oral Health. 2024 Apr 4;24(1):414. doi: 10.1186/s12903-024-04201-0.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 3, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 80758; 1UG3DE032621-01 (U.S. NIH Grant/Contract); 4UH3DE032621-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No