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.

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. - Changes in oral microflora and salivary proteins in irradiated patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33881

Enrollment

Registered

2010-01-21

Start date

2009-09-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mondafwijkingen dry mouth hyposalivation

Interventions

group A brushed there teeth twice a day with a fluoride toothpaste of there choice and applies a 0.45% neutral fluoride gel in a customized tray once every two days. group B brushes there teeth twic

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
composition of salivary proteins, microbial composition of saliva and plaque, DMFS (decayed, missing, filled surfaces)/DMFT (decayed, missing, filled teeth) scores, bleeding on probing scores	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)