To determine the difference in secondary caries lesion development in tooth samples with simulated restorations from different restorative materials and to relate this to the microbial composition and acid production capacity of biofilm taken from…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cariës
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Lesion depth and integrated mineral loss of (recurrent) caries lesions
Secondary outcome
Biofilm composition and acidogenicity
Background summary
The presence of a non-biological material when a restoration is placed may
influence the secondary caries process in several ways. The material
properties, such as a lack in buffering capacity, may influence the development
and composition of the biofilm and/or the chemical process.
Study objective
To determine the difference in secondary caries lesion development in tooth
samples with simulated restorations from different restorative materials and to
relate this to the microbial composition and acid production capacity of
biofilm taken from those samples. The effect of antibacterial components of the
material will be evaluated.
Study design
A mono-center, single-blind in situ study, with split mouth design.
Study burden and risks
The burden for participating volunteers exists of wearing a (copy) lower
denture in which tooth samples are placed during a period of 8 weeks. During
this time they will have to dip the denture in sucrose solution several times
per day. They will visit the laboratory site once every 4 weeks. Swallowing one
of the tooth samples is a relative risk, however, this has never occurred in a
previous study (NL 28303.091.09).
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
>= 18 years and <=75 years
healthy ( no disease, no medication, ASA I)
wearing denture
Persons with salivary flow al least within normal range (unstimulated >= 0.2 ml/min; chewing stimulated >= 0.7 ml/min)
Exclusion criteria
Persons under medication that affects immunological system or salivary glands.
Persons with systemic diseases influencing oral and salivary function.
Seriously ill persons (ASA > 2)
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 | NL33526.091.11 |