Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05877170
Status:
RECRUITING
Last Update Posted:
2023-05-26
First Post:
2023-05-15
Brief Title:
Impact of Palmitoylethanolamide PEA in the Management of Oro-facial Pain
Sponsor:
University of Catania
Organization:
University of Catania
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None