Written by Chrystal Moulton, Staff Writer.  At 180min, both CBD groups had a maximum pain reduction of 73% from baseline.

Considering the recent opioid crisis, health care providers need alternative pain-relieving medicine. Particularly, in patients with severe toothache, Ibuprofen or acetaminophen is the most prescribed medicine1. However, for patients who do not respond to NSAIDs or acetaminophen, hydrocodone or oxycodone, a common opioid, is routinely prescribed1,2. In states where the medical use of marijuana is legal, opioid prescriptions dropped between five and eight percent3. Some evidence suggests that CBD has efficacious analgesic properties for chronic pain and neuropathy4,5. Unlike marijuana, CBD is neither addictive nor psychoactive6. In the current clinical trial, researchers investigated the safety and effectiveness of an FDA approved CBD drug for use on emergency dental pain7.

The study was designed a randomized, double-blind, placebo-controlled, phase IIA trial. The FDA approved a drug, Epidiolex, previously approved for treatment of epileptic seizures in patients 2 years old or more. It is an oil-based oral solution with a maximum dose of 20mg/kg/d. Epidiolex, however, is not approved for dental pain. Healthy adults aged 18 to 75 years old with moderate to severe tooth pain and diagnosis of symptomatic apical periodontitis, irreversible pulpitis, or pulpal necrosis were recruited for this trial. Participants also had to test negative for drug and alcohol use. Eligible participants were randomly assigned to 1 of 3 groups:

  1. CBD10- Epidiolex 10mg/kg/d
  2. CBD20- Epidiolex 20mg/kg/d
  3. Placebo- sesame oil + ORA Sweet solution

Participants were randomly assigned in a 1:1:1 ratio. At baseline, demographic data, pain intensity (VAS scale), bite force, and questionnaires on mood and psychoactive change were conducted. Upon intake of their assigned treatment, the data was collected again at 15, 30, 45, 60, 90, 120, and 180 minutes. A questionnaire on adverse events was also given at those times. The primary outcome measure was change in VAS score from baseline and secondary outcomes included onset of pain relief, maximum pain relief, change in pain intensity and bite force, psychoactive and mood changes, and any adverse events. Participants were given Ibuprofen and acetaminophen as rescue drugs but were asked to take them only if needed at 180min. Use of rescue medication was also tracked. Seven days later, researchers followed up with the participants for any additional side effects post treatment.

Sixty- four subjects were enrolled in this study.  Of them, 3 participants were excluded.  The final distribution of subjects in each group is as follows:

  1. CBD10 n= 20
  2. CBD20 n= 20
  3. Placebo n= 21

Of the total 61 participants eligible for the study, 65.5% were females and 34.5% males with an average age of 44 ±13.7 years old.  Majority of participants were of Hispanic or Latino descent (68%) followed by Caucasian (11%). No significant difference was observed between groups in demographics or the use of rescue medication after the 180min observation period.

TABLE 1. Median VAS Scores (0-100) at Baseline and 180min

CBD20 CBD10 Placebo
Baseline 69 63 63
180 min 20 * 21 * 48

*p<0.05 compared to placebo

At 15 min from baseline, participants in the CBD20 began experiencing significant pain relief. For the CBD10 group, significant pain relief began at 30min from baseline. By 60min and 120 min, the CBD20 and CBD10 groups saw a 50% reduction in pain scores, respectively. At 180min, both CBD groups had a maximum pain reduction of 73% from baseline with median pain scores at 27% of baseline scores. In the placebo group, at 180min, the median pain score was 67% of baseline with a 33% reduction from baseline. When compared to placebo, both CBD groups showed significant pain reduction at 180 min (p<0.05). However, CBD20 also demonstrated significant pain reduction at 120min compared to placebo (p<0.05). Researchers also observed a significant interaction between pain reduction and time (p<0.001).

TABLE 2. Median Bite Force Scores

CBD20 CBD10
Baseline 53 61
90min 59 * 86 *
180min 66 * 80 *

*within group comparison (p< 0.05)

No significant differences were observed in bite force within the placebo group. Average bite force scores significantly increased in CBD20 group compared to placebo when bite force scores were normalized across all groups (p<0.05). For adverse events, compared to placebo, diarrhea, sedation, and abdominal pain were the most significant side effects in both CBD groups (p<0.05).

Overall results demonstrated the FDA approved CBD drug Epidiolex was effective in managing severe tooth pain. Additional research would be needed to verify these results. Epidiolex is not approved for use in dental pain and therefore will need further review by FDA for such use.

Source: Chrepa, V., S. Villasenor, A. Mauney, Georgios Kotsakis, and L. Macpherson. “Cannabidiol as an Alternative Analgesic for Acute Dental Pain.” Journal of dental research (2023): 00220345231200814.

© International Association for Dental, Oral, and Craniofacial Research and American Association for Dental, Oral, and Craniofacial Research 2023

Click here to read the full text study.

Posted January 31, 2024.

Chrystal Moulton BA, PMP, is a 2008 graduate of the University of Illinois at Chicago. She graduated with a bachelor’s in psychology with a focus on premedical studies and is a licensed project manager. She currently resides in Indianapolis, IN.

References:

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  2. Steinmetz CN, Zheng C, Okunseri E, Szabo A, Okunseri C. Opioid Analgesic Prescribing Practices of Dental Professionals in the United States. JDR Clin Trans Res. Jul 2017;2(3):241-248. doi:10.1177/2380084417693826
  3. Bradford AC, Bradford WD. Medical Marijuana Laws May Be Associated With A Decline In The Number Of Prescriptions For Medicaid Enrollees. Health Aff (Millwood). May 1 2017;36(5):945-951. doi:10.1377/hlthaff.2016.1135
  4. Xu DH, Cullen BD, Tang M, Fang Y. The Effectiveness of Topical Cannabidiol Oil in Symptomatic Relief of Peripheral Neuropathy of the Lower Extremities. Current pharmaceutical biotechnology. 2020;21(5):390-402. doi:10.2174/1389201020666191202111534
  5. Capano A, Weaver R, Burkman E. Evaluation of the effects of CBD hemp extract on opioid use and quality of life indicators in chronic pain patients: a prospective cohort study. Postgrad Med. Jan 2020;132(1):56-61. doi:10.1080/00325481.2019.1685298
  6. Babalonis S, Haney M, Malcolm RJ, et al. Oral cannabidiol does not produce a signal for abuse liability in frequent marijuana smokers. Drug Alcohol Depend. Mar 1 2017;172:9-13. doi:10.1016/j.drugalcdep.2016.11.030
  7. Chrepa V, Villasenor S, Mauney A, Kotsakis G, Macpherson L. Cannabidiol as an Alternative Analgesic for Acute Dental Pain. J Dent Res. Nov 1 2023:220345231200814. doi:10.1177/00220345231200814