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

University of Catania

Status: Enrolling

Conditions: Oral-facial Pain

Treatments: Drug: Placebo; Dietary Supplement: Palmitoyletinolamide

Study type: Interventional

Funder types: Other

Identifiers

NCT05877170

121-25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

PEA

Experimental group

Description:

PEA-containing nutraceutical agent in oral formulation

Treatment:

Dietary Supplement: Palmitoyletinolamide

Placebo

Placebo Comparator group

Description:

Patients treated with a placebo

Treatment:

Drug: Placebo