NCT02661243

Implantology and Sjögren's Syndrome

Implantology and Sjögren's Syndrome: a Multicenter Prospective Cohort Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Derk Jan Jager · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Sjogren's Syndrome

Interventions

Type	Name	Description
DEVICE	Biohorizons Laser-lok bonelevel dental implants	Insertion of Biohorizons Laser-lok bonelevel dental implants to replace missing (pre)molars or to stabilize a denture

Timeline

• Start date: 2015-05-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2016-01-22
• Last updated: 2019-04-30

Locations

5 sites across 1 country: Netherlands