Alternatives to Dental Opioid Prescribing After Tooth Extraction

NCT06275191 | Enrolling By Invitation

• 3 other identifiers: 807581UG3DE032621-014UH3DE032621-02
• Study Type: interventional
• Target: 38,159
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• (Change in) intervention feasibility

  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

  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

  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

  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

  within 10 days of tooth extraction

Study Arms (2)

Intervention condition

EXPERIMENTAL

1. Academic detailing (45 to 60-minute session), plus 2. Provision of standardized patient post-extraction instructions for distribution, plus 3. 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

Control condition

ACTIVE COMPARATOR

Usual practice

Other: Usual care

Interventions

Multicomponent intervention BEHAVIORAL

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

Intervention condition

Usual care OTHER

No intervention.

Control condition

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Douglas Oyler: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (4)

• 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.

  PMID: 36905202 BACKGROUND

• 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.

  PMID: 35691709 BACKGROUND

• 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.

  PMID: 33632410 BACKGROUND

• 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.

  PMID: 38575929 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas R Oyler, PharmD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Marcia V Rojas Ramirez, DDS

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding to the intervention is not possible in this study, as the intervention requires provider engagement. Provider participants and any clinic personnel will be blinded to the allocation sequence, and those not yet receiving the intervention will not be aware of the time at which they will have the intervention implemented. The study biostatistician will be aware of the allocation sequence. At the beginning of each period, the study biostatistician will inform the research coordinator, project manager, academic detailing pharmacist, and PIs which cluster will be transitioning to the intervention condition next. This information will be used to facilitate scheduling academic detailing visits and coordinate blister pack and patient instructions material assembly. The clinic will be informed of their allocation during Visit 4 to facilitate scheduling academic detailing visits.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Stepped wedge cluster randomized trial

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 23, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)