This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05877170
Recruitment Status : Recruiting
First Posted : May 26, 2023
Last Update Posted : May 26, 2023
Sponsor:
Information provided by (Responsible Party):
Gaetano Isola, University of Catania

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Oral-facial Pain Dietary Supplement: Palmitoyletinolamide Drug: Placebo Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : August 12, 2023
Estimated Study Completion Date : August 17, 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: PEA
PEA-containing nutraceutical agent in oral formulation
 Dietary Supplement: Palmitoyletinolamide
Taking a once-daily supplement containing PEA in an oral formulation (tablets), to be taken away from meals
Placebo Comparator: Placebo
Patients treated with a placebo
 Drug: Placebo
Taking a placebo in an oral formulation (tablets), to be taken away from meals


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05877170


Contacts
Layout table for location contacts
Contact: Gaetano Isola 0953785652 gaetano.isola@unict.it
Contact: Rosalia Leonardi rleonard@unict.it

Locations
Layout table for location information
Italy
AOU Policlinico G. Rodolico Recruiting
Catania, Italy, 95124
Sponsors and Collaborators
University of Catania
Investigators
Layout table for investigator information
Principal Investigator: Gaetano Isola University of Catania
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Gaetano Isola, Principal Researcher, University of Catania
ClinicalTrials.gov Identifier: NCT05877170    
Other Study ID Numbers: 121-25
First Posted: May 26, 2023    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Facial Pain
Pain
Neurologic Manifestations