18 and older, any sex, with Partly Edentulous Maxilla. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change of Bone LevelPrimary· 0, 12, 24 months
Intra-oral radiographs from implant insertion and at time for prosthesis insertion as well as from 1 and 2-year follow-up visits (calculated from the time of loading) should be taken for evaluation of bone level. All radiographs will be examined by an independent dentist.
For the purpose of this examination XCP film holder (DENTSPLY Rinn, 1212 Abbott Drive, Elgin, Illinois 60123-1819, USA) are individualized for each subject and for each x-ray.
Mean change of marginal bone loss 12 months after loading.
Group
Value
95% CI
Abutment-supported XiVE CAD/CAM Bridge
-0.34
± 0.65
Implant-supported XiVE CAD/CAM Bridge
-0.15
± 0.42
Mean change of marginal bone loss 24 months after loading.
The evaluation of the sulcus fluid flow rate (SFFR) is a common method for the objective definition of the gingiva inflammation level in clinical research. The SFFR is measured with an electronic sulcus fluid hygrometer, and always as the first procedure in order not to be influenced by other investigation parameters.
The hydrometer values results are generally classified in the categories healthy (0-20), slightly irritated (21-40), moderately irritated (\< 100) and strongly inflamed (\> 100). For this clinical investigation no absolute values, but relative values were compared. The SFFR valu
SFFR at 6 weeks post loading.
Group
Value
95% CI
Abutment-supported XiVE CAD/CAM Bridge
18
Implant-supported XiVE CAD/CAM Bridge
24
Abutment-supported XiVE CAD/CAM Bridge
11
Implant-supported XiVE CAD/CAM Bridge
4
Abutment-supported XiVE CAD/CAM Bridge
6
Implant-supported XiVE CAD/CAM Bridge
7
Abutment-supported XiVE CAD/CAM Bridge
3
Implant-supported XiVE CAD/CAM Bridge
2
SFFR at 6 months post loading.
Group
Value
95% CI
Abutment-supported XiVE CAD/CAM Bridge
18
Implant-supported XiVE CAD/CAM Bridge
19
Abutment-supported XiVE CAD/CAM Bridge
9
Implant-supported XiVE CAD/CAM Bridge
7
Abutment-supported XiVE CAD/CAM Bridge
6
Implant-supported XiVE CAD/CAM Bridge
10
Abutment-supported XiVE CAD/CAM Bridge
5
Implant-supported XiVE CAD/CAM Bridge
2
SFFR at 12 months post loading.
Group
Value
95% CI
Abutment-supported XiVE CAD/CAM Bridge
22
Implant-supported XiVE CAD/CAM Bridge
17
Abutment-supported XiVE CAD/CAM Bridge
6
Implant-supported XiVE CAD/CAM Bridge
11
Abutment-supported XiVE CAD/CAM Bridge
7
Implant-supported XiVE CAD/CAM Bridge
7
Abutment-supported XiVE CAD/CAM Bridge
1
Implant-supported XiVE CAD/CAM Bridge
1
SFFR at 24 months post loading.
Group
Value
95% CI
Abutment-supported XiVE CAD/CAM Bridge
20
Implant-supported XiVE CAD/CAM Bridge
24
Abutment-supported XiVE CAD/CAM Bridge
5
Implant-supported XiVE CAD/CAM Bridge
4
Abutment-supported XiVE CAD/CAM Bridge
11
Implant-supported XiVE CAD/CAM Bridge
7
Abutment-supported XiVE CAD/CAM Bridge
0
Implant-supported XiVE CAD/CAM Bridge
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 24 months post loading..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dentsply Implants Manufacturing GmbH
Last refreshed: 13 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01522365.