N/A
N=40
XiVE® CAD/CAM Bridges (Abutment-supported/ Implant-supported)
Partly Edentulous Maxilla
Bottom Line
View on ClinicalTrials.gov: NCT01522365 ↗Enrolled (actual)
40
Serious AEs
3.5%
Results posted
Sep 2022
Primary outcome: Primary: Mean Change of Bone Level — -0.34; -0.15; -0.24; -0.12 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Abutment-supported XiVE CAD/CAM bridge (Device); Implant-supported XiVE CAD/CAM bridge (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dentsply Implants Manufacturing GmbH
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change of Bone Level |
-0.34; -0.15; -0.24; -0.12 | — |
| SECONDARY Sulcus-fluid-flow-rate |
18; 24; 11; 4; 6; 7 | — |
Summary
This study has been designed in order to collect data with regards to the peri-implant tissue outcome of abutment-supported restoration and direct implant-fixed restoration. Therefore a small group of subjects with partly edentulous maxilla is selected to show that both techniques are efficient and safe and to show comparable peri-implant tissue outcome for both methods. At the time of impression forming for each centre treatment A (= abutment-supported XiVE® CAD/CAM supra-structure) and B (= direct implant-fixed XiVE® CAD/CAM supra-structure) is assigned to the left and right side of the maxilla by being randomized at the time of impression forming.
Eligibility Criteria
Inclusion Criteria
- Subject > 18 years.
- Female subject of child-bearing potential must use reliable methods of contraception.
- Subject has partly edentulous maxilla (free-end or large gap in posterior area on both sides).
- For all implants immobility and clear percussion sound is applicable.
- The subject is healthy and compliant with good oral hygiene.
- Favorable and stable occlusal relationship between the remaining teeth.
- Subject must be reliable, cooperative, and in the opinion of the Investigator, likely to be compliant with study procedures.
- Subject provides written informed consent signed and dated prior to entering the study.
- Implantation of XiVE® implants at least 3 months ago.
- XiVE® implants have been placed primary stable by considering sufficient horizontal and vertical bone dimension.
Exclusion Criteria
- Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous year.
- Subject with planned or performed head and neck radiation.
- Known unavailability of subject for FU Visit(s).
- Subject has - in the opinion of the investigator - any systemic metabolic disorder or bone disorder or is taking medication that compromises or might have compromised post-operative tissue regeneration or osseointegration.
- Subject has major bone defects in the implantation area.
- Subject is taking medication that compromises or might have compromised post-operative healing and/or osseointegration (e. g. bisphosphonates).
- Subject exhibits an oral infection.
- Subject has received any investigational drug within 30 days prior to screening.
- Severe bruxing.
- Subject has a clinically significant or unstable medical or physiological condition.
- Female subject is pregnant or lactating or intends to become pregnant during the course of the study.
- Subject is not willing to participate in the study or not able to understand the content of the study.
Data sourced from ClinicalTrials.gov (NCT01522365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.