Impact of Palmitoylethanolamide (PEA) in the Management of Oro-facial Pain
Primary Purpose
Oral-facial Pain
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Palmitoyletinolamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Oral-facial Pain
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
Sites / Locations
- AOU Policlinico G. RodolicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PEA
Placebo
Arm Description
PEA-containing nutraceutical agent in oral formulation
Patients treated with a placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05877170
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
August 12, 2023 (Anticipated)
Study Completion Date
August 17, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral-facial Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEA
Arm Type
Experimental
Arm Description
PEA-containing nutraceutical agent in oral formulation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients treated with a placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Palmitoyletinolamide
Intervention Description
Taking a once-daily supplement containing PEA in an oral formulation (tablets), to be taken away from meals
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Taking a placebo in an oral formulation (tablets), to be taken away from meals
Primary Outcome Measure Information:
Title
Reduction of oral-facial pain
Description
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
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaetano Isola
Phone
0953785652
Email
gaetano.isola@unict.it
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalia Leonardi
Email
rleonard@unict.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
University of Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Impact of Palmitoylethanolamide (PEA) in the Management of Oro-facial Pain
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