Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

Phase 3

Completed

• Conditions: Pain, Acute
• Interventions: Drug: acetaminophen 500mg and ibuprofen 200mg combo; Drug: placebo; Drug: cannabidiol

• Registration Number: NCT04271917
• Lead Sponsor: University of Tennessee

Brief Summary

The purpose of this study is to evaluate the analgesic effects of cannabidiol for patients who have undergone simple tooth extraction. Participants will be randomized to one of four arms: treatment-as-usual (TAU), cannabidiol 17mg/mL, cannabidiol 37mg/mL, or placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-17
• Study Start: 2020-02-24
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Presenting for an operatory appointment at University of Tennessee Health Science Center College of Dentistry Oral and Maxillofacial Surgery Department
• Operation must be a simple tooth extraction which does not result in an opioid prescription
• 18 years of age or older
• Have regular and direct access to a device that can send and receive texts and willing to accept any associated charges for 24 text messages

Exclusion Criteria

• Contraindication to ibuprofen
• Contraindication to acetaminophen
• Contraindication to cannabidiol or hemp oil
• Contraindication to peppermint oil
• Contraindication to almond or other tree nuts
• Currently taking a form of cannabidiol and unwilling to stop use for one week post surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment As Usual (TAU)	acetaminophen 500mg and ibuprofen 200mg combo	Participants will receive a 5-day supply of acetaminophen 500mg and ibuprofen 200mg. Instructions for use: Take one tablet of each medication at the same time every 4-6 hours as needed for pain.
Placebo	placebo	Participants will receive a 5-day supply (15mL) of inactive placebo in a dropper vial. Instructions for use: Place 0.5mL of oil under tongue for 30 seconds then swallow. Use every 4-6 hours as needed for pain.
CBD 17mg/mL	cannabidiol	Participants will receive a 5-day supply (15mL) of cannabidiol 17mg/mL. Instructions for use: Place 0.5mL of oil under tongue for 30 seconds then swallow. Use every 4-6 hours as needed for pain.
CBD 37 mg/mL	cannabidiol	Participants will receive a 5-day supply (15mL) of cannabidiol 37mg/mL. Instructions for use: Place 0.5mL of oil under tongue for 30 seconds then swallow. Use every 4-6 hours as needed for pain.

Primary Outcome Measures

Name	Time	Method
Pain levels following surgery using Wong Baker Faces pain scale	First 72 hours post-op	Self-reported pain recorded every 2 hours between 7am-9pm by automated SMS messaging.
Amount of medication used	1-week post-op	Self-report of total amount of pain medication used from participant diary
Worst pain following surgery using Wong Baker Faces pain scale	1-week post-op	Self-report of participant's worst pain after surgery

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States