Partially Edentulous Patients
Conditions
Keywords
dental implants, SLActive® surface, biomarkers, BLT implant
Brief summary
This post-market study is to show that dental implants with a SLActive® surface (SLActive® implants) show non-inferior clinical performance compared to dental implants with a SLA® surface (SLA® implants). The primary hypothesis is that 12 months after implant loading, the bone loss around the SLActive® implants will not be appreciably greater than around the SLA® implants. The occurrence of adverse events and device deficiencies will also be recorded to confirm once more the safety of the Straumann® Bone Level Tapered (BLT), Roxolid® implant. Osseointegration and anti-inflammatory potential of SLActive® implants will be evaluated in the study as secondary endpoints.
Detailed description
This is a prospective, single-blinded, randomized, paired sample, multi-center clinical study. Eight visits per patient are scheduled in this study. The final analysis will be conducted after all patients completed the 12-month visit. The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use. Two centers in Spain will participate.
Interventions
DEVICESLActive® 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.
DEVICESLA® 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.
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* males and females, at least 18 years old * partially edentulous patients in need of two or more dental implants (canine to molars) placed in two different quadrants in healed sites (3 months post extraction) * subject must have voluntarily signed the informed consent, is willing and able to attend scheduled follow-up visits, and agrees that the encoded data will be collected and analyzed
Exclusion criteria
* any contraindications for oral surgical procedures * dental implant placement contraindicated according to Instructions for Use (IFU) * subjects with inadequate oral hygiene (FMPS ≥ 20%) * subjects who are currently heavy smokers (defined \>10 cigarettes per day or \>1 cigar per day) or who use chewing tobacco * subjects with drug or alcohol abuse * patients requiring soft tissue and bone grafting procedures * inadequate bone volume * severe bruxism or clenching habits * women who are pregnant or planning to become pregnant at any point during the study duration. * patients who have systemic factors that could interfere with the healing process of either bone or soft tissue or the osseointegration process (e.g. bone metabolism disturbances, uncontrolled diabetes mellitus, anticoagulation drugs/ hemorrhagic diatheses) * patients with local factors that could interfere with the healing process, such as untreated periodontal diseases, acute infection of implant site, temporomandibular joint disorders, treatable pathologic diseases of the jaw and changes in the oral mucosa) * conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Level Change 12 Months After Implant Loading | 12 months after implant loading | 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). |
| Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect | 12 months after implant loading | Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | At implant placement, 1 and 4 weeks after implant placement | 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. |
| Change in Osseointegration Biomarkers Concentrations | 1, 2, 4 and 8 weeks after implant placement | Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples. |
| Implant Survival | 12 months after implant loading | Implant survival at 12 months after implant loading |
Countries
Spain
Participant flow
Recruitment details
Patients were screened at 2 investigational centers in Spain
Pre-assignment details
A total of 70 patients were screened. Of those, 68 subjects were enrolled
Participants by arm
| Arm | Count |
|---|---|
| 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. | 68 |
| 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. | 68 |
| 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. | 68 |
| 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. | 68 |
| Total | 272 |
Baseline characteristics
| Characteristic | Total | SLA® Implant | SLActive® Implant |
|---|---|---|---|
| Age, Continuous | 56 years | 56 years | 56 years |
| Number of Implants | 1.2 Implants STANDARD_DEVIATION 1.9 | 1.2 Implants STANDARD_DEVIATION 1.9 | 1.2 Implants STANDARD_DEVIATION 1.9 |
| Number of missing teeth | 10.5 Teeth STANDARD_DEVIATION 4.9 | 10.5 Teeth STANDARD_DEVIATION 4.9 | 10.5 Teeth STANDARD_DEVIATION 4.9 |
| Number of planned implants | 3.1 Implants STANDARD_DEVIATION 1 | 3.1 Implants STANDARD_DEVIATION 1 | 3.1 Implants STANDARD_DEVIATION 1 |
| Race/Ethnicity, Customized Ethnicity Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity European | 134 Participants | 67 Participants | 67 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 70 Participants | 35 Participants | 35 Participants |
| Sex: Female, Male Male | 66 Participants | 33 Participants | 33 Participants |
| Smoking status (never, past, current) Current smoker (<= 10 cigarettes per day) | 20 Participants | 10 Participants | 10 Participants |
| Smoking status (never, past, current) Current smoker (> 10 cigarettes per day) | 0 Participants | 0 Participants | 0 Participants |
| Smoking status (never, past, current) Current smoker (>1 cigar per day) | 0 Participants | 0 Participants | 0 Participants |
| Smoking status (never, past, current) Current smoker (1 cigar per day) | 0 Participants | 0 Participants | 0 Participants |
| Smoking status (never, past, current) Current smoker (e-cigs) | 0 Participants | 0 Participants | 0 Participants |
| Smoking status (never, past, current) Never smoked | 52 Participants | 26 Participants | 26 Participants |
| Smoking status (never, past, current) Past smoker (<10 years since cessation) | 26 Participants | 13 Participants | 13 Participants |
| Smoking status (never, past, current) Past smoker (>=10 years since cessation) | 38 Participants | 19 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 68 |
| other Total, other adverse events | 26 / 68 | 26 / 68 |
| serious Total, serious adverse events | 2 / 68 | 2 / 68 |
Outcome results
Primary
Bone Level Change 12 Months After Implant Loading
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).
Time frame: 12 months after implant loading
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SLActive® Implant | Bone Level Change 12 Months After Implant Loading | 0.214 mm | Standard Deviation 0.391 |
| SLA® Implant | Bone Level Change 12 Months After Implant Loading | 0.056 mm | Standard Deviation 0.093 |
p-value: 0.074t-test, 1 sided
Primary
Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect
Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect
Time frame: 12 months after implant loading
Population: The SAF populations defined as all patients who were enrolled in the study and who received a study device
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SLActive® Implant | Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect | Number of ADE | 14 events |
| SLActive® Implant | Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect | Number of DD | 0 events |
| SLA® Implant | Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect | Number of ADE | 20 events |
| SLA® Implant | Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect | Number of DD | 0 events |
Secondary
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
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.
Time frame: At implant placement, 1 and 4 weeks after implant placement
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-6) at implant placement | 437.4 picograms per milliliter | Standard Deviation 1056.2 |
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-6) at implant Week 4 | 17.2 picograms per milliliter | Standard Deviation 77.4 |
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-1B) at implant placement | 11.3 picograms per milliliter | Standard Deviation 26.8 |
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-1B) at Week 4 | 29.2 picograms per milliliter | Standard Deviation 65.8 |
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (TNF-a) at implant placement | 13.3 picograms per milliliter | Standard Deviation 36.4 |
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (TNF-a) at Week 4 | 14.2 picograms per milliliter | Standard Deviation 25.7 |
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-2) at implant placement | 1.9 picograms per milliliter | Standard Deviation 3.1 |
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-2) at Week 1 | 0.4 picograms per milliliter | Standard Deviation 0.5 |
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Anti-inflammation (IL-10) at implant placement | 18.3 picograms per milliliter | Standard Deviation 35.2 |
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Anti-inflammation (IL-10) at Week 4 | 22.5 picograms per milliliter | Standard Deviation 40 |
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Anti-inflammation (IL-4) at implant placement | 3.7 picograms per milliliter | Standard Deviation 7.3 |
| SLActive® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Anti-inflammation (IL-4) at Week 4 | 3.3 picograms per milliliter | Standard Deviation 3.6 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Anti-inflammation (IL-4) at implant placement | 5.7 picograms per milliliter | Standard Deviation 14.5 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-6) at implant placement | 508.3 picograms per milliliter | Standard Deviation 1296.7 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-2) at implant placement | 1.7 picograms per milliliter | Standard Deviation 2.8 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-6) at implant Week 4 | 8.6 picograms per milliliter | Standard Deviation 38.5 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Anti-inflammation (IL-10) at Week 4 | 28.0 picograms per milliliter | Standard Deviation 51.3 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-1B) at implant placement | 8.4 picograms per milliliter | Standard Deviation 17.2 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-2) at Week 1 | 0.9 picograms per milliliter | Standard Deviation 2 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (IL-1B) at Week 4 | 35.2 picograms per milliliter | Standard Deviation 88.1 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Anti-inflammation (IL-4) at Week 4 | 3.6 picograms per milliliter | Standard Deviation 4.5 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (TNF-a) at implant placement | 13.0 picograms per milliliter | Standard Deviation 30.1 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Anti-inflammation (IL-10) at implant placement | 17.7 picograms per milliliter | Standard Deviation 44.4 |
| SLA® Implant | Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations | Inflammation (TNF-a) at Week 4 | 20.1 picograms per milliliter | Standard Deviation 46.3 |
Secondary
Change in Osseointegration Biomarkers Concentrations
Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.
Time frame: 1, 2, 4 and 8 weeks after implant placement
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SLActive® Implant | Change in Osseointegration Biomarkers Concentrations | VEGF-a at implant placement | 39.3 picograms per milliliter | Standard Deviation 295.2 |
| SLActive® Implant | Change in Osseointegration Biomarkers Concentrations | VEGF-a at 4 weeks | 73.6 picograms per milliliter | Standard Deviation 504.4 |
| SLActive® Implant | Change in Osseointegration Biomarkers Concentrations | OCN at implant placement | 760.3 picograms per milliliter | Standard Deviation 1394.5 |
| SLActive® Implant | Change in Osseointegration Biomarkers Concentrations | OCN at 8 weeks | 159.8 picograms per milliliter | Standard Deviation 79.6 |
| SLActive® Implant | Change in Osseointegration Biomarkers Concentrations | OPN at implant placement | 6064.2 picograms per milliliter | Standard Deviation 11713.2 |
| SLActive® Implant | Change in Osseointegration Biomarkers Concentrations | OPN at 8 weeks | 939.3 picograms per milliliter | Standard Deviation 1677.1 |
| SLA® Implant | Change in Osseointegration Biomarkers Concentrations | OPN at implant placement | 4419.0 picograms per milliliter | Standard Deviation 7887 |
| SLA® Implant | Change in Osseointegration Biomarkers Concentrations | VEGF-a at implant placement | 26.0 picograms per milliliter | Standard Deviation 272.7 |
| SLA® Implant | Change in Osseointegration Biomarkers Concentrations | OCN at 8 weeks | 117.7 picograms per milliliter | Standard Deviation 76.3 |
| SLA® Implant | Change in Osseointegration Biomarkers Concentrations | VEGF-a at 4 weeks | 28.6 picograms per milliliter | Standard Deviation 573.5 |
| SLA® Implant | Change in Osseointegration Biomarkers Concentrations | OPN at 8 weeks | 876.6 picograms per milliliter | Standard Deviation 1789.8 |
| SLA® Implant | Change in Osseointegration Biomarkers Concentrations | OCN at implant placement | 2408.6 picograms per milliliter | Standard Deviation 8935.4 |
Secondary
Implant Survival
Implant survival at 12 months after implant loading
Time frame: 12 months after implant loading
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SLActive® Implant | Implant Survival | 3 number of lost implants |
| SLA® Implant | Implant Survival | 2 number of lost implants |