The objective of the study is to map the changes in the composition of salivary proteins as a consequence of irradiation of the salivary glands, to study how the composition of oral microflora changes as a consequence of irradiation and whether it…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
mondafwijkingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
not applicable
Background summary
5% of all new tumors in the Netherlands is lokalised in the head and neck area.
The incidence is increasing. The treatment strategy for this kind of tumors
usually consists of surgery, often in combination with radiation. Irradiation
of the head and neck area has a lot of side effects in the oral cavity. One of
the frequent side effects is the onset of a dry mouth because irradiated
glandulartissue dies and not enough saliva is being produced. Speech,
swallowing and mastication are hampered. Furthermore the oral health seriously
declines. Patients can develop rampant caries. The current preventive
measurements are not yet sufficient. In the future there is a need for good
preventive measurements that can slow down the onset of caries. At this moment
the knowledge about the role of salivary proteins and oral bacteria in
developing rampant caries is limited.
Study objective
The objective of the study is to map the changes in the composition of salivary
proteins as a consequence of irradiation of the salivary glands, to study how
the composition of oral microflora changes as a consequence of irradiation and
whether it is possible to influence that in a positive way.
Study design
The study has a prospective, single-blind, randomized, controlled design.
Intervention
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 twice a day with Meridol toothpaste and rinses
additionally twice a day with Meridol mouthrinse.
Study burden and risks
The burden for participants exists of 4 appointments of 30 mintes in which
saliva (total saliva and parotid saliva) and plaque are sampled. Furthermore
they have to stick to the prescribed oral hygiene protocol and write down every
week how often they used the prescribed products.
The risk for participants are assessed as very low, due to the fact that there
are no known side effects of the prescribed oral hygiene protocols.
Leeuwenveldseweg 5N
1382 LV Weesp
NL
Leeuwenveldseweg 5N
1382 LV Weesp
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25236.031.09 |