Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217731
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2024-01-06
Brief Title:
Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome
Sponsor:
Universidad de Murcia
Organization:
Universidad de Murcia
Study Overview
Official Title:
Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome Before and After Treatment With Low-Level Laser Therapy and Clonazepam A Randomized Single-Blind Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-01
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:
burningmouth
Brief Summary:
Burning Mouth Syndrome BMS is a chronic pain disorder that presents with inflammation and burning sensation in the oral cavity without visible lesions Multiple therapies have been investigated without conclusive resultsObjective To analyse the efficacy of treatment with Clonazepam Rivotril and Low Power Diode Laser Therapy in patients with Burning Mouth Syndrome and to study the markers of inflammation present in the patients saliva
Methods Randomised single-blind clinical trial with 89 patients divided into Group 1 Laser Rivotril n20 Group 2 Laser Sham placebo n19 Group 3 Laser n21 and Group 4 Rivotril n18 The intensity of symptomatology was rated by Visual Analogue Scale VAS Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory the Oral Health Impact Profile-14 OHIP14 and the Mini-Nutritional Assessment MNA were completed Saliva samples were analysed by measuring markers related to inflammatory processes Interleukins IL2 IL4 IL 5 IL6 IL 7 IL 8 IL1β IL 10 IL12 IL13 IL17 IL21 IL23 proteins MIP-3α MIP-1α MIP-1β Cytokine GM-CSF Interferon gamma IFNγ Interferon Inducible Tα-Cell Chemoattractant ITAC Fractalkine and Tumour Necrosis Factor αTNFα
Methods Randomised single-blind clinical trial with 89 patients divided into Group 1 Laser Rivotril n20 Group 2 Laser Sham placebo n19 Group 3 Laser n21 and Group 4 Rivotril n18 The intensity of symptomatology was rated by Visual Analogue Scale VAS Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory the Oral Health Impact Profile-14 OHIP14 and the Mini-Nutritional Assessment MNA were completed Saliva samples were analysed by measuring markers related to inflammatory processes Interleukins IL2 IL4 IL 5 IL6 IL 7 IL 8 IL1β IL 10 IL12 IL13 IL17 IL21 IL23 proteins MIP-3α MIP-1α MIP-1β Cytokine GM-CSF Interferon gamma IFNγ Interferon Inducible Tα-Cell Chemoattractant ITAC Fractalkine and Tumour Necrosis Factor αTNFα
Detailed Description:
Methods Randomised single-blind clinical trial with 89 patients divided into Group 1 Laser Rivotril n20 Group 2 Laser Sham placebo n19 Group 3 Laser n21 and Group 4 Rivotril n18 The intensity of symptomatology was rated by Visual Analogue Scale VAS Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory the Oral Health Impact Profile-14 OHIP14 and the Mini-Nutritional Assessment MNA were completed Saliva samples were analysed by measuring markers related to inflammatory processes Interleukins IL2 IL4 IL 5 IL6 IL 7 IL 8 IL1β IL 10 IL12 IL13 IL17 IL21 IL23 proteins MIP-3α MIP-1α MIP-1β Cytokine GM-CSF Interferon gamma IFNγ Interferon Inducible Tα-Cell Chemoattractant ITAC Fractalkine and Tumour Necrosis Factor αTNFα
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