Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

Pain, Acute Clinical Trial

— SWAP  

Official title:

Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271917
• Other study ID #: 20-07123-XP
• Status: Completed
• Phase: Phase 3
• Start date: February 24, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Drug:
• cannabidiol
Use of cannabidiol as an alternative to standard of care treatment of acute pain.
• placebo
Inactive placebo oil to imitate CBD oil
• acetaminophen 500mg and ibuprofen 200mg combo
standard of care

Locations

Country	Name	City	State
United States	University of Tennessee Health Science Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

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