Impact of Palmitoylethanolamide (PEA) in the Management of Oro-facial Pain

• ClinicalTrials.gov Identifier: NCT05877170
• Recruitment Status: Recruiting
• First Posted: May 26, 2023
• Last Update Posted: May 26, 2023
• Sponsor: University of Catania
• Information provided by (Responsible Party): Gaetano Isola, University of Catania

Tracking Information

• First Submitted Date: May 15, 2023
• First Posted Date: May 26, 2023
• Last Update Posted Date: May 26, 2023
• Actual Study Start Date: February 18, 2020
• Estimated Primary Completion Date: August 12, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 23, 2023)

Reduction of oral-facial pain [ Time Frame: 3 Months ]

• The short-term and long-term effects of PEA on the management of neuropathic pain of the oro-facial district.
• The short-term effects of PEA on the management of nociceptive pain of the oro-facial district.

Visual Pain Analog Scale (VAS) will be used for pain assessment, in which the value 0 indicates no pain and the value 100 the maximum pain. The Oral Health Impact Profile Short For will be used to assess the impact of oral problems on quality of life, in which the presence or absence of physical pain, functional limitation, psychological distress, physical disability, physiological disability will be assessed

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of Palmitoylethanolamide (PEA) in the Management of Oro-facial Pain
• Official Title: Evaluation of the Analgesic and Anti-inflammatory Activities of a Nutraceutical Agent Containing PEA in the Management of Patients With Orofacial Pain, Both Neuropathic and Nociceptive in Nature

Brief Summary

Pain is the most common symptom faced by dentists, whether acute (pulpitis, acute periodontitis, post-surgical, etc.) or chronic (chronic periodontitis, muscle pain, TMJ disorders, BMS, OLP, etc.). The success of therapy depends on the reduction and management of pain. Therefore, over the past few years, the need has emerged, also in relation to the aging population, to analyze new molecules with pain-relieving activity and with low risk of inducing side effects and interactions with other drugs; capable of bringing about the reduction of oro-facial pain; and that lend themselves to prolonged use. Palmitoylethanolamide (PEA) is a bioactive lipid mediator similar to endocannabinoids (eCBs) that has been observed to have anti-inflammatory, analgesic, anticonvulsant, antimicrobial, antipyretic, antiepileptic, immunomodulatory, and neuroprotective activities.

The objective is to clinically study, through a clinical trial, the pain-relieving and anti-inflammatory properties of a PEA-containing nutraceutical agent in the management of patients with orofacial pain, both neuropathic and nociceptive in nature.

Detailed Description

A double-blind placebo-controlled study was conducted to evaluate the efficacy of Palmitoyletinolamide (PEA) and determine the statistical significance of its action.

40 patients with both acute and chronic orofacial pain were divided into two groups: study group given a nutraceutical agent containing PEA and a control group given a placebo. A three-month follow-up will be conducted.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Oral-facial Pain

Intervention

• Dietary Supplement: Palmitoyletinolamide
  Taking a once-daily supplement containing PEA in an oral formulation (tablets), to be taken away from meals
• Drug: Placebo
  Taking a placebo in an oral formulation (tablets), to be taken away from meals

Study Arms

• Experimental: PEA
  PEA-containing nutraceutical agent in oral formulation
  Intervention: Dietary Supplement: Palmitoyletinolamide
• Placebo Comparator: Placebo
  Patients treated with a placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 23, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 17, 2023
• Estimated Primary Completion Date: August 12, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• good general health condition,
• presence of diffuse or localized oro-facial pain of nociceptive nature or postoperative pain,
• presence of diffuse or localized oro-facial pain of neuropathic nature for at least 1 month.

Exclusion Criteria:

• Allergies,
• debilitating systemic diseases,
• pregnancy status
• severe cognitive impairment

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Gaetano Isola; 0953785652; gaetano.isola@unict.it

Contact: Rosalia Leonardi; rleonard@unict.it

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT05877170
• Other Study ID Numbers: 121-25
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol

• Current Responsible Party: Gaetano Isola, University of Catania
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Catania
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gaetano Isola; University of Catania

• PRS Account: University of Catania
• Verification Date: May 2023