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Behavioral Intervention

Alternatives to Opioids for Pain After Tooth Extraction (ADOPT Trial)

N/A
Waitlist Available
Led By Douglas R Oyler, PharmD
Research Sponsored by Douglas Oyler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be aged 12-25 at the time of tooth extraction
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up same calendar date as dental extraction. electronic health records will be extracted for the duration of the 4-year study period.
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test a new intervention for oral surgeons who remove teeth to see if it can reduce opioid prescriptions to adolescents and young adults after the procedure. The study will also evaluate if the intervention changes

Who is the study for?
This trial is for adolescents and young adults who are having teeth removed. Oral surgeons participating will need to attend an educational session, provide specific pain medications, and complete surveys. Patients must take a survey about their pain and medication use post-extraction.
What is being tested?
The study tests if a three-part intervention can cut down opioid prescriptions after tooth removal compared to usual care. It includes education for oral surgeons, special patient instructions, and blister packs of non-opioid pain medicine.
What are the potential side effects?
Since the focus is on reducing opioid use by providing alternatives like acetaminophen or ibuprofen, side effects may include typical reactions to these drugs such as stomach upset or mild allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 25 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~same calendar date as dental extraction. electronic health records will be extracted for the duration of the 4-year study period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and same calendar date as dental extraction. electronic health records will be extracted for the duration of the 4-year study period. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction
Secondary study objectives
(Change in) intervention appropriateness
(Change in) intervention feasibility
(Change in) opioid prescribing appropriateness
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention conditionExperimental Treatment1 Intervention
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
Group II: Control conditionActive Control1 Intervention
Usual practice
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multicomponent intervention
2014
Completed Phase 3
~7990

Find a Location

Who is running the clinical trial?

Douglas OylerLead Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)NIH
307 Previous Clinical Trials
811,961 Total Patients Enrolled
Douglas R Oyler, PharmDPrincipal InvestigatorUniversity of Kentucky
Marcia V Rojas Ramirez, DDSPrincipal InvestigatorUniversity of Kentucky
~25439 spots leftby Jan 2028