Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
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|ClinicalTrials.gov Identifier: NCT00381771|
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : July 28, 2010
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.
|Condition or disease||Intervention/treatment|
|Globus Pharyngeus||Behavioral: Conservative management for xerostomia|
Subjects: patients with symptoms of globus pharyngeus
Globus symptom scoring: 0(mild) to 5(severe)
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)
- Group 1: Globus patients with objective salivary hypofunction
- 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 Type :||Observational|
|Actual Enrollment :||340 participants|
|Official Title:||Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||December 2007|
Objective salivary function
Based on the salivary scintigraphy,
Behavioral: Conservative management for xerostomia
Active hydration (drinking more than 10 cups of water per day), Humidification, Oral gargle with a diluted (0.05% to 0.1%) chlorhexidine solution, Sugarless chewing gum, Saliva-stimulating sour juice (sugarless orange juice), Commercial artificial saliva, Nasal saline spray 3 to 4 times a day, Warm massage of the 4 major salivary glands.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381771
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Han-Sin Jeong, M.D||Samsung Medical Center, Dept of Otorhinolaryngology-Head and Neck Surgery|