Prospective study for the changes in oral microflora and the composition of salivary proteins in patients, who receive radiation therapy for a tumor in the head and neck area.

• Conditions: mondafwijkingen; dry mouth; hyposalivation

• Registration Number: NL-OMON33881
• Lead Sponsor: GABA Benelux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

-Curative irradiation of the head and neck area with a prescription dose of 56 Gy or more
- Target areas of irradiation at least bilateral neck at the height of level II
- At least one to two posterior elements on the side of the mouth that receives most radiation (elements that must be extracted for treatment are not included)
- Age > 18 years

Exclusion Criteria

-previous treatment for a tumor in the head and neck area
-surgical removal of (part of) the parotid gland

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>composition of salivary proteins, microbial composition of saliva and plaque,<br /><br>DMFS (decayed, missing, filled surfaces)/DMFT (decayed, missing, filled teeth)<br /><br>scores, bleeding on probing scores</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>