Sjogren's Syndrome Clinical Trial
Official title:
Implantology and Sjögren's Syndrome: a Multicenter Prospective Cohort Study
Until now it has not been investigated whether placement of implants in SS patients is less successful than compared to non-SS patients. The risk factors and the efficacy of dental implants in dry mouth patients are not known because of the lack of scientific evidence. The aim of this study is to investigate changes in marginal peri-implant bone loss and the clinical performance of dental implants in SS patients compared to implants in healthy patients.
Rationale: Until now it has not been investigated whether placement of implants in SS
patients is less successful than compared to non-SS patients. The risk factors and the
efficacy of dental implants in dry mouth patients are not known because of the lack of
scientific evidence.
Objective: to investigate changes in marginal peri-implant bone loss and the clinical
performance of dental implants in SS patients compared to implants in healthy patients.
Study design: A prospective multicenter clinical trial.
Study population: N = 120
Intervention: All patients receive Biohorizons Laser-lok bonelevel implants to replace the
missing (pre)molars or to support a full denture in the upper and lower jaw .
This study is comprised of four study groups:
- 30 human adults affected by SS with the need of replacement of missing premolars or
molars in the upper or lower jaw.
- 30 healthy human adults with the need of replacement of missing premolars or molars in
the upper or lower jaw.
- 30 human edentulous adults affected by SS with the need of stabilization of the
dentures.
- 30 healthy human edentulous adults with the need of stabilization of the dentures.
Main study parameters/endpoints: changes in marginal peri-implant bone loss of dental
implants between the healthy and SS groups and differences in clinical performance 1.5 years
after finalization.
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