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Completed

NCT Number: NCT04642404

CBD for Dental Pain

The purpose of this study is to evaulate CBD as a therapeutic approach for dental pain. Eligible subjects presented with emergency dental pain will be give a single dose of Epidiolex (FDA-approved CBD) or placebo and will be monitored for 3 hours for pain symptoms and psychologic effects.

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Key information

Conditions

Odontalgia Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

CBD is a non-psychoactive, non-addictive compound of cannabis that has shown analgesic and anti-inflammatory properties. Epidiolex is the only FDA-approved oral CBD solution and will be the drug of choice in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults 18-75 years old, ASA I or II
  • permanent tooth with moderate to severe odontogenic pain, i.e. ≥30 on a 100mm VAS,
  • clinical pulpal diagnosis of irreversible pulpitis or pulpal necrosis, and periapical diagnosis of symptomatic apical periodontitis
  • test negative for recent cannabis use and/or other drugs of abuse including alcohol (urine tests collected at screening visit), and participant
  • able to understand the forms (English or Spanish) and provide informed written consent.

Exclusion criteria

  • ASA Class III or IV
  • patients with hepatic impairment
  • pregnant or lactating women
  • Patients on drugs metabolized by enzymes that also metabolize CBD (e.g. clobazam, diazepam, topiramate, warfarin)
  • self-reported prior experience inhaling cannabis (either via smoking or vaporization), use of opioids in the month prior to screening/treatment visit, and/or NSAIDS or acetaminophen 6 hours prior to treatment
  • unwilling to participate.

Treatment and study plan

Epidiolex 100 mg/mL Oral Solution

Drug

Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain

Other names: Cannabidiol (CBD)

Placebo

Drug

Placebo drug will be a solution with the same taste, texture and color as the drug.

Primary outcomes

  1. Intra-group VAS Pain Intensity and Maximum Pain Relief

    Time frame: Baseline to 180 minutes

    Patients will report their pain level using a 100mm Visual Analogue Scale at baseline, measured at baseline and 180 minutes. Score is measured on a 100mm scale, scored 0-100, with a lower score indicating less pain.

  2. Bite Force Measurement

    Time frame: Baseline, 90 minutes and 180 minutes

    Bite force is measured by biting down on the Bite Fork at various times to measure change in value. The digital bite transducer is a previously validated instrument used to assess changes in the bite forces (N) before and after the intervention.

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 3 hours and 7 Days

    Included: Psychoactive effects, mood changes, and report other side effects after single dose of Epidiolex

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

Cannabidiol (CBD) for the Management of Emergency Dental Pain

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 24, 2020
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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