Trial Outcomes & Findings for Dental Implants With a SLActive® vs. SLA® Surface (NCT NCT03737357)
NCT ID: NCT03737357
Last Updated: 2025-06-12
Results Overview
The primary efficacy objective of this study was to confirm the performance of the SLActive® implants by means of bone level change 12 months after implant loading, as described in the CIP (CR2017-05, v03).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
12 months after implant loading
Results posted on
2025-06-12
Participant Flow
Patients were screened at 2 investigational centers in Spain
A total of 70 patients were screened. Of those, 68 subjects were enrolled
Unit of analysis: Implants
Participant milestones
| Measure |
SLActive® Implant
SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
SLA® Implant
SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
|---|---|---|
|
Overall Study
STARTED
|
68 68
|
68 68
|
|
Overall Study
COMPLETED
|
61 61
|
61 61
|
|
Overall Study
NOT COMPLETED
|
7 7
|
7 7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dental Implants With a SLActive® vs. SLA® Surface
Baseline characteristics by cohort
| Measure |
SLActive® Implant
n=68 Implants
SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
SLA® Implant
n=68 Implants
SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
Total
n=136 Implants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
56 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · European
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Smoking status (never, past, current)
Never smoked
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Smoking status (never, past, current)
Past smoker (<10 years since cessation)
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Smoking status (never, past, current)
Past smoker (>=10 years since cessation)
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Smoking status (never, past, current)
Current smoker (<= 10 cigarettes per day)
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Smoking status (never, past, current)
Current smoker (1 cigar per day)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Smoking status (never, past, current)
Current smoker (> 10 cigarettes per day)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Smoking status (never, past, current)
Current smoker (>1 cigar per day)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Smoking status (never, past, current)
Current smoker (e-cigs)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Number of missing teeth
|
10.5 Teeth
STANDARD_DEVIATION 4.9 • n=5 Participants
|
10.5 Teeth
STANDARD_DEVIATION 4.9 • n=7 Participants
|
10.5 Teeth
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Number of Implants
|
1.2 Implants
STANDARD_DEVIATION 1.9 • n=63 Implants
|
1.2 Implants
STANDARD_DEVIATION 1.9 • n=85 Implants
|
1.2 Implants
STANDARD_DEVIATION 1.9 • n=148 Implants
|
|
Number of planned implants
|
3.1 Implants
STANDARD_DEVIATION 1.0 • n=63 Implants
|
3.1 Implants
STANDARD_DEVIATION 1.0 • n=85 Implants
|
3.1 Implants
STANDARD_DEVIATION 1.0 • n=148 Implants
|
PRIMARY outcome
Timeframe: 12 months after implant loadingPopulation: Per protocol Population: defined as each eligible study subject with one study control and one study test implant and who performed all follow-up visits.
The primary efficacy objective of this study was to confirm the performance of the SLActive® implants by means of bone level change 12 months after implant loading, as described in the CIP (CR2017-05, v03).
Outcome measures
| Measure |
SLActive® Implant
n=55 Participants
SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
SLA® Implant
n=55 Participants
SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
|---|---|---|
|
Bone Level Change 12 Months After Implant Loading
|
0.214 mm
Standard Deviation 0.391
|
0.056 mm
Standard Deviation 0.093
|
PRIMARY outcome
Timeframe: 12 months after implant loadingPopulation: The SAF populations defined as all patients who were enrolled in the study and who received a study device
Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect
Outcome measures
| Measure |
SLActive® Implant
n=68 Participants
SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
SLA® Implant
n=68 Participants
SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
|---|---|---|
|
Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect
Number of ADE
|
14 events
|
20 events
|
|
Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect
Number of DD
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: At implant placement, 1 and 4 weeks after implant placementPopulation: Intention To Treat (ITT) population: each eligible and randomized study patient who received control and test implants in two different quadrants and from whom at least one follow-up measurement after placement is available.
Change in inflammatory and anti-inflammatory biomarkers (IL-10, IL-4, IL-6, IL-1beta, TNF-alpha, IL-2) concentrations in gingival crevicular fluid samples.
Outcome measures
| Measure |
SLActive® Implant
n=68 Participants
SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
SLA® Implant
n=68 Participants
SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
|---|---|---|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Inflammation (IL-6) at implant placement
|
437.4 picograms per milliliter
Standard Deviation 1056.2
|
508.3 picograms per milliliter
Standard Deviation 1296.7
|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Inflammation (IL-6) at implant Week 4
|
17.2 picograms per milliliter
Standard Deviation 77.4
|
8.6 picograms per milliliter
Standard Deviation 38.5
|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Inflammation (IL-1B) at implant placement
|
11.3 picograms per milliliter
Standard Deviation 26.8
|
8.4 picograms per milliliter
Standard Deviation 17.2
|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Inflammation (IL-1B) at Week 4
|
29.2 picograms per milliliter
Standard Deviation 65.8
|
35.2 picograms per milliliter
Standard Deviation 88.1
|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Inflammation (TNF-a) at implant placement
|
13.3 picograms per milliliter
Standard Deviation 36.4
|
13.0 picograms per milliliter
Standard Deviation 30.1
|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Inflammation (TNF-a) at Week 4
|
14.2 picograms per milliliter
Standard Deviation 25.7
|
20.1 picograms per milliliter
Standard Deviation 46.3
|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Inflammation (IL-2) at implant placement
|
1.9 picograms per milliliter
Standard Deviation 3.1
|
1.7 picograms per milliliter
Standard Deviation 2.8
|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Inflammation (IL-2) at Week 1
|
0.4 picograms per milliliter
Standard Deviation 0.5
|
0.9 picograms per milliliter
Standard Deviation 2.0
|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Anti-inflammation (IL-10) at implant placement
|
18.3 picograms per milliliter
Standard Deviation 35.2
|
17.7 picograms per milliliter
Standard Deviation 44.4
|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Anti-inflammation (IL-10) at Week 4
|
22.5 picograms per milliliter
Standard Deviation 40.0
|
28.0 picograms per milliliter
Standard Deviation 51.3
|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Anti-inflammation (IL-4) at implant placement
|
3.7 picograms per milliliter
Standard Deviation 7.3
|
5.7 picograms per milliliter
Standard Deviation 14.5
|
|
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Anti-inflammation (IL-4) at Week 4
|
3.3 picograms per milliliter
Standard Deviation 3.6
|
3.6 picograms per milliliter
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 1, 2, 4 and 8 weeks after implant placementPopulation: ITT population: each eligible and randomized study patient who received control and test implants in two different quadrants and from whom at least one follow-up measurement after placement is available.
Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.
Outcome measures
| Measure |
SLActive® Implant
n=68 Participants
SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
SLA® Implant
n=68 Participants
SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
|---|---|---|
|
Change in Osseointegration Biomarkers Concentrations
OPN at 8 weeks
|
939.3 picograms per milliliter
Standard Deviation 1677.1
|
876.6 picograms per milliliter
Standard Deviation 1789.8
|
|
Change in Osseointegration Biomarkers Concentrations
VEGF-a at implant placement
|
39.3 picograms per milliliter
Standard Deviation 295.2
|
26.0 picograms per milliliter
Standard Deviation 272.7
|
|
Change in Osseointegration Biomarkers Concentrations
VEGF-a at 4 weeks
|
73.6 picograms per milliliter
Standard Deviation 504.4
|
28.6 picograms per milliliter
Standard Deviation 573.5
|
|
Change in Osseointegration Biomarkers Concentrations
OCN at implant placement
|
760.3 picograms per milliliter
Standard Deviation 1394.5
|
2408.6 picograms per milliliter
Standard Deviation 8935.4
|
|
Change in Osseointegration Biomarkers Concentrations
OCN at 8 weeks
|
159.8 picograms per milliliter
Standard Deviation 79.6
|
117.7 picograms per milliliter
Standard Deviation 76.3
|
|
Change in Osseointegration Biomarkers Concentrations
OPN at implant placement
|
6064.2 picograms per milliliter
Standard Deviation 11713.2
|
4419.0 picograms per milliliter
Standard Deviation 7887.0
|
SECONDARY outcome
Timeframe: 12 months after implant loadingPopulation: ITT population - defined as each eligible and randomized study patient who received control and test implants in two different quadrants and from whom at least one follow-up measurement after placement is available
Implant survival at 12 months after implant loading
Outcome measures
| Measure |
SLActive® Implant
n=68 Participants
SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
SLA® Implant
n=68 Participants
SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
|---|---|---|
|
Implant Survival
|
3 number of lost implants
|
2 number of lost implants
|
Adverse Events
SLActive® Implant
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
SLA® Implant
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SLActive® Implant
n=68 participants at risk
SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
SLA® Implant
n=68 participants at risk
SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
1.5%
1/68 • 12 months
|
1.5%
1/68 • 12 months
|
|
Nervous system disorders
Hernia
|
1.5%
1/68 • 12 months
|
1.5%
1/68 • 12 months
|
Other adverse events
| Measure |
SLActive® Implant
n=68 participants at risk
SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
SLA® Implant
n=68 participants at risk
SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
|
|---|---|---|
|
Product Issues
Mechanical complications
|
8.8%
6/68 • Number of events 6 • 12 months
|
8.8%
6/68 • Number of events 6 • 12 months
|
|
General disorders
Biological Complications
|
14.7%
10/68 • Number of events 10 • 12 months
|
14.7%
10/68 • Number of events 10 • 12 months
|
|
General disorders
Other complications
|
4.4%
3/68 • Number of events 3 • 12 months
|
4.4%
3/68 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Biological Complications - hard tissue related
|
13.2%
9/68 • Number of events 9 • 12 months
|
13.2%
9/68 • Number of events 9 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place