Trial Outcomes & Findings for XiVE® CAD/CAM Bridges (Abutment-supported/ Implant-supported) (NCT NCT01522365)
NCT ID: NCT01522365
Last Updated: 2022-09-13
Results Overview
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.
COMPLETED
NA
20 participants
0, 12, 24 months
2022-09-13
Participant Flow
Split-mouth design, i.e. each subject is randomized to both treatments. The total number of subjects enrolled were 20 (41 implants per treatment arm and thus 82 implants in total). 19 subjects were treated with the investigational medical devices (38 implants per treatment arm and thus 76 implants in total - ITT-population). 18 subjects completed the study (36 implants per treatment arm and thus 72 implants in total).
Unit of analysis: implants
Participant milestones
| Measure |
Abutment-supported XiVE CAD/CAM Bridge
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed on an abutment.
Abutment-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment
|
Implant-supported XiVE CAD/CAM Bridge
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed directly on an implant.
Implant-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant
|
|---|---|---|
|
Overall Study
STARTED
|
20 41
|
20 41
|
|
Overall Study
Intention-to-Treat
|
19 38
|
19 38
|
|
Overall Study
COMPLETED
|
18 36
|
18 36
|
|
Overall Study
NOT COMPLETED
|
2 5
|
2 5
|
Reasons for withdrawal
| Measure |
Abutment-supported XiVE CAD/CAM Bridge
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed on an abutment.
Abutment-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment
|
Implant-supported XiVE CAD/CAM Bridge
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed directly on an implant.
Implant-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Split-mouth study design.
Baseline characteristics by cohort
| Measure |
Abutment-supported XiVE CAD/CAM Bridge
n=38 implants
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed on an abutment.
Abutment-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment
|
Implant-supported XiVE CAD/CAM Bridge
n=38 implants
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed directly on an implant.
Implant-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant
|
Total
n=76 implants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
54.4 Years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
54.4 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants • Split-mouth study design.
|
18 Participants
n=7 Participants • Split-mouth study design.
|
36 Participants
n=5 Participants • Split-mouth study design.
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants • Split-mouth study design.
|
1 Participants
n=7 Participants • Split-mouth study design.
|
2 Participants
n=5 Participants • Split-mouth study design.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Split-mouth study design.
|
0 Participants
n=7 Participants • Split-mouth study design.
|
0 Participants
n=5 Participants • Split-mouth study design.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Split-mouth study design.
|
0 Participants
n=7 Participants • Split-mouth study design.
|
0 Participants
n=5 Participants • Split-mouth study design.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Split-mouth study design.
|
0 Participants
n=7 Participants • Split-mouth study design.
|
0 Participants
n=5 Participants • Split-mouth study design.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants • Split-mouth study design.
|
2 Participants
n=7 Participants • Split-mouth study design.
|
4 Participants
n=5 Participants • Split-mouth study design.
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants • Split-mouth study design.
|
17 Participants
n=7 Participants • Split-mouth study design.
|
34 Participants
n=5 Participants • Split-mouth study design.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Split-mouth study design.
|
0 Participants
n=7 Participants • Split-mouth study design.
|
0 Participants
n=5 Participants • Split-mouth study design.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Split-mouth study design.
|
0 Participants
n=7 Participants • Split-mouth study design.
|
0 Participants
n=5 Participants • Split-mouth study design.
|
PRIMARY outcome
Timeframe: 0, 12, 24 monthsPopulation: There is only one analysis set in this clinical investigation: the Intention-to-Treat (ITT) analysis set. The ITT analysis set comprise all randomized subjects who fulfilled the inclusion criteria but none of the exclusion criteria. Subjects not fulfilling the eligibility criteria i.e. violating at least one of the inclusion criteria or fulfilling at least one of the exclusion criteria are not included in the ITT analysis set.
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.
Outcome measures
| Measure |
Abutment-supported XiVE CAD/CAM Bridge
n=36 Implants
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed on an abutment.
Abutment-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment
|
Implant-supported XiVE CAD/CAM Bridge
n=36 Implants
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed directly on an implant.
Implant-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant
|
|---|---|---|
|
Mean Change of Bone Level
Mean change of marginal bone loss 12 months after loading.
|
-0.34 mm
Standard Deviation 0.65
|
-0.15 mm
Standard Deviation 0.42
|
|
Mean Change of Bone Level
Mean change of marginal bone loss 24 months after loading.
|
-0.24 mm
Standard Deviation 0.75
|
-0.12 mm
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: 6 weeks, 6, 12, 24 monthsPopulation: There is only one analysis set in this clinical investigation: the Intention-to-Treat (ITT) analysis set. The ITT analysis set comprise all randomized subjects who fulfilled the inclusion criteria but none of the exclusion criteria. Subjects not fulfilling the eligibility criteria i.e. violating at least one of the inclusion criteria or fulfilling at least one of the exclusion criteria are not included in the ITT analysis set.
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 values measured for each implant at Visit 1 were defined as "zero point-values". The respective first natural tooth in mesial direction served as control. All values obtained at the following visits for each implant were compared to the appropriate reference value (zero point).
Outcome measures
| Measure |
Abutment-supported XiVE CAD/CAM Bridge
n=38 Implants
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed on an abutment.
Abutment-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment
|
Implant-supported XiVE CAD/CAM Bridge
n=38 Implants
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed directly on an implant.
Implant-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant
|
|---|---|---|
|
Sulcus-fluid-flow-rate
SFFR at 6 months post loading. · >100 strongly inflamed)
|
5 Implants
|
2 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 12 months post loading. · 0-20 (healthy)
|
22 Implants
|
17 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 6 weeks post loading. · 0-20 (healthy)
|
18 Implants
|
24 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 6 weeks post loading. · 21-40 (slightly irritated)
|
11 Implants
|
4 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 6 weeks post loading. · <100 (moderately irritated)
|
6 Implants
|
7 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 6 weeks post loading. · >100 strongly inflamed)
|
3 Implants
|
2 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 6 months post loading. · 0-20 (healthy)
|
18 Implants
|
19 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 6 months post loading. · 21-40 (slightly irritated)
|
9 Implants
|
7 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 6 months post loading. · <100 (moderately irritated)
|
6 Implants
|
10 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 12 months post loading. · 21-40 (slightly irritated)
|
6 Implants
|
11 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 12 months post loading. · <100 (moderately irritated)
|
7 Implants
|
7 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 12 months post loading. · >100 strongly inflamed)
|
1 Implants
|
1 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 24 months post loading. · 0-20 (healthy)
|
20 Implants
|
24 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 24 months post loading. · 21-40 (slightly irritated)
|
5 Implants
|
4 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 24 months post loading. · <100 (moderately irritated)
|
11 Implants
|
7 Implants
|
|
Sulcus-fluid-flow-rate
SFFR at 24 months post loading. · >100 strongly inflamed)
|
0 Implants
|
1 Implants
|
Adverse Events
Abutment-supported XiVE CAD/CAM Bridge
Implant-supported XiVE CAD/CAM Bridge
All Study Participants
Serious adverse events
| Measure |
Abutment-supported XiVE CAD/CAM Bridge
n=19 participants at risk
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed on an abutment.
Abutment-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment
|
Implant-supported XiVE CAD/CAM Bridge
n=19 participants at risk
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed directly on an implant.
Implant-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant
|
All Study Participants
n=19 participants at risk
Any event that cannot be attributed to the randomized interventions.
|
|---|---|---|---|
|
Surgical and medical procedures
Partial thyroidectomy
|
0.00%
0/19 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
|
Injury, poisoning and procedural complications
Tibia/Fibula fracture
|
0.00%
0/19 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
Other adverse events
| Measure |
Abutment-supported XiVE CAD/CAM Bridge
n=19 participants at risk
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed on an abutment.
Abutment-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment
|
Implant-supported XiVE CAD/CAM Bridge
n=19 participants at risk
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed directly on an implant.
Implant-supported XiVE CAD/CAM bridge: One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant
|
All Study Participants
n=19 participants at risk
Any event that cannot be attributed to the randomized interventions.
|
|---|---|---|---|
|
Product Issues
Dental bridge loosening/fracture
|
0.00%
0/19 • Up to 24 months post loading.
|
15.8%
3/19 • Number of events 3 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/19 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
|
Infections and infestations
Frontal sinusitis
|
0.00%
0/19 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
|
Eye disorders
Blocked tear duckt
|
0.00%
0/19 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
|
Cardiac disorders
Heart murmur
|
0.00%
0/19 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
|
Musculoskeletal and connective tissue disorders
Lack of keratinized tissue
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
|
Product Issues
Veneer porcelain fracture
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
|
Product Issues
Abutment screw loose.
|
10.5%
2/19 • Number of events 2 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
|
Product Issues
Composite cover loosening
|
5.3%
1/19 • Number of events 3 • Up to 24 months post loading.
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/19 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
10.5%
2/19 • Number of events 2 • Up to 24 months post loading.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/19 • Up to 24 months post loading.
|
0.00%
0/19 • Up to 24 months post loading.
|
5.3%
1/19 • Number of events 1 • Up to 24 months post loading.
|
Additional Information
Director Center of Clinical Research, AnnaKarin Lundgren
Dentsply Sirona Implants
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60