Peri-implant Dermatitis Clinical Trial
Official title:
The Baha Microbiome Case Control Study A Molecular Bacterial Profile Of The Baha Part 1 of the Baha Microbiome Study
The Bone-Anchored Hearing Aid (Baha) system consists of an implanted part and sound
processor. The system provides a hearing solution for a subgroup of patients who cannot
sufficiently profit from conventional hearing aids. Disadvantageous are its high rate (up to
40%) of associated peri-implant dermatitis. This research project is part of an attempt to
reduce the amount of peri-implant dermatitis. Besides an attempt of Holgers to identify the
skin flora in relation to infection around the abutment using a standard culture which
yielded limited and no clinically relevant results, little is known about the microbiome on
the abutment or its interaction with the commensal skin flora. Moreover, conventional
cultures are not very sensitive in identifying bacteria. In 2010, Budding et al. introduced
IS-pro. Is-pro is a novel 16S-23S rDNA interspace (IS)- region-based profiling method. This
technology was devised to enable high-throughput molecular fingerprinting of microbioma.
Since IS-pro is quick and relatively inexpensive, these environments can also be monitored
over time by repeating the test. This paves the way for researching the microbiome on the
abutment and it could enable clinically objective follow up of treatments in vivo using the
human as a host. This technique allows researchers to even discover unknown, previously
unidentified bacteria. Additionally, Scanning Electron Microscopy will be used to assess the
spatial distribution and composition of bacteria on the abutment. The first step, using
these techniques, is to determine the bacteria which inhabit the abutment also in relation
to the surrounding skin. Additionally, the relationship with skin-implant infections and the
effect of treatments will be monitored. Depending on these primary scientific results, a
subsequent study will be devised to study (experimental) treatments in a randomized,
controlled fashion.
Objectives of the study:
1. To identify the bacterial flora on the abutment in a phylum/species classification.
2. To assess the relationships between the commensal skin flora and the flora on the
abutment and to study if clinical signs of peri-implant skin infection and subsequent
treatment are associated with a change in bacterial composition.
3. To assess if there exists a relationship between skin hygiene and the transient skin
flora.
n/a
Observational Model: Case Control, Time Perspective: Prospective