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

Not Applicable

Recruiting

• Conditions: Oral-facial Pain
• Interventions: Dietary Supplement: Palmitoyletinolamide; Drug: Placebo

• Registration Number: NCT05877170
• Lead Sponsor: University of Catania

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 Timeline

• Study Start: 2020-02-18
• Status Verified: 2023-05
• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Study First Posted: 2023-05-26
• Last Update Posted: 2023-05-26
• Primary Completion: 2023-08-12
• Study Completion: 2023-08-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEA	Palmitoyletinolamide	PEA-containing nutraceutical agent in oral formulation
Placebo	Placebo	Patients treated with a placebo

Primary Outcome Measures

Name	Time	Method
Reduction of oral-facial pain	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

Trial Locations

Locations (1)

AOU Policlinico G. Rodolico; 🇮🇹 Catania, Italy