NCT00381771

Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 340 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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) 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)

Conditions

• Globus Pharyngeus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-08-01
• Completion: 2007-12-01
• First posted: 2006-09-28
• Last updated: 2010-07-28

Locations

1 site across 1 country: South Korea