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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Oral-facial Pain

Intervention / Treatment
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* Dietary Supplement: Palmitoyletinolamide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |