Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381771
Status:
COMPLETED
Last Update Posted:
2010-07-28
First Post:
2006-09-27
Brief Title:
Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
Status:
COMPLETED
Status Verified Date:
2010-07
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:
It is well known that globus sensation in throat is caused by the chronic irritation and inflammation of oral pharyngeal or laryngeal mucosa such as laryngopharyngeal reflux and chronic postnasal drip
Xerostomia and pharyngoxerosis due to salivary hypofunction also proved to induce the mucosal change of the oral cavity and pharynx
However no previous studies have documented the prevalence of salivary hypofunction in patients with globus pharyngeus
Through this clinical investigation we hypothesized that the salivary hypofunction might be one of the leading cause of globus pharyngeus
Xerostomia and pharyngoxerosis due to salivary hypofunction also proved to induce the mucosal change of the oral cavity and pharynx
However no previous studies have documented the prevalence of salivary hypofunction in patients with globus pharyngeus
Through this clinical investigation we hypothesized that the salivary hypofunction might be one of the leading cause of globus pharyngeus
Detailed Description:
Subjects patients with symptoms of globus pharyngeus
Globus symptom scoring 0mild to 5severe
Subjective symptom analysis by Standard Table for Xerostomia and Pharyngoxerosis
Subjective physical finding analysis by Standard Table for Xerostomia and Pharyngoxerosis
Objective analysis of Salivary function by 99m-Tc Salivary scintigraphy
-- Define the prevalence of salivary hypofunction in patients with globus pharyngeus Primary end point
Subsequent analysis Secondary end point
1 Group 1 Globus patients with objective salivary hypofunction
2 Group 2 Globus patients with normal salivary function
Intervention Active management for xerostomia Moisturizing Gargling Humidification Massage of salivary gland Stimulant of salivary secretion Artificial saliva
Evaluation of the change of globus symptoms after active management of xerostomia between the Group 1 and Group 2 at 1 months at 3 months after the initiation of intervention
Globus symptom scoring 0mild to 5severe
Subjective symptom analysis by Standard Table for Xerostomia and Pharyngoxerosis
Subjective physical finding analysis by Standard Table for Xerostomia and Pharyngoxerosis
Objective analysis of Salivary function by 99m-Tc Salivary scintigraphy
-- Define the prevalence of salivary hypofunction in patients with globus pharyngeus Primary end point
Subsequent analysis Secondary end point
1 Group 1 Globus patients with objective salivary hypofunction
2 Group 2 Globus patients with normal salivary function
Intervention Active management for xerostomia Moisturizing Gargling Humidification Massage of salivary gland Stimulant of salivary secretion Artificial saliva
Evaluation of the change of globus symptoms after active management of xerostomia between the Group 1 and Group 2 at 1 months at 3 months after the initiation of intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None