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

NCT05877170 | Unknown

• 1 other identifier: 121-25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral-facial Pain

Outcome Measures

Primary Outcomes (1)

• Reduction of oral-facial pain

  * 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

  3 Months

Study Arms (2)

PEA

EXPERIMENTAL

PEA-containing nutraceutical agent in oral formulation

Dietary Supplement: Palmitoyletinolamide

Placebo

PLACEBO COMPARATOR

Patients treated with a placebo

Drug: Placebo

Interventions

Palmitoyletinolamide DIETARY_SUPPLEMENT

Taking a once-daily supplement containing PEA in an oral formulation (tablets), to be taken away from meals

PEA

Placebo DRUG

Taking a placebo in an oral formulation (tablets), to be taken away from meals

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

RECRUITING

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaetano Isola

  University of Catania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano Isola

CONTACT

0953785652; gaetano.isola@unict.it

Rosalia Leonardi

CONTACT

rleonard@unict.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 26, 2023
• Study Start: February 18, 2020
• Primary Completion: August 12, 2023
• Study Completion: August 17, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (1)