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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEA | Experimental | PEA-containing nutraceutical agent in oral formulation |
|
| Placebo | Placebo Comparator | Patients treated with a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palmitoyletinolamide | Dietary Supplement | Taking a once-daily supplement containing PEA in an oral formulation (tablets), to be taken away from meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of oral-facial pain |
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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaetano Isola | Contact | 0953785652 | gaetano.isola@unict.it | |
| Rosalia Leonardi | Contact | rleonard@unict.it |
| Name | Affiliation | Role |
|---|---|---|
| Gaetano Isola | University of Catania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Policlinico G. Rodolico | Recruiting | Catania | 95124 | Italy |
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| ID | Term |
|---|---|
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Taking a placebo in an oral formulation (tablets), to be taken away from meals |
|