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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLActive® implant | Experimental |
| |
| SLA® implant | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLActive® implant | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months after implant loading |
| 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 | 12 months after implant loading |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At implant placement, 1 and 4 weeks after implant placement |
| Change in Osseointegration Biomarkers Concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Sanz, Prof. Dr. | Professor and Chairman of Periodontology | Principal Investigator |
| Juan Blanco-Carrión, Prof. Dr. | Professor in Periodontology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Complutense | Madrid | Spain | ||||
| Universidad de Santiago de Compostela |
A total of 70 patients were screened. Of those, 68 subjects were enrolled
Patients were screened at 2 investigational centers in Spain
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study used a split-mouth design. Each participant received both SLActive® and SLA® implants. As a result, the same 68 participants appear under both arms. The Total column reflects the number of unique participants (N=68).
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Deviation | mm | 12 months after implant loading |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal fistula | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mechanical complications | Product Issues | Systematic Assessment | Including fracture/chipping of prosthesis; loosening of Abutment/Occlusal screw; Loss/failure of a healing cap; the crown doesn't fit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anaïs Robert, Clinical Trial Leader | Institut Straumann | +41799258750 | anais.robert@straumann.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2020 | Apr 17, 2024 | Prot_SAP_000.pdf |
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|
| SLA® implant | Device | 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 ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples. |
| 1, 2, 4 and 8 weeks after implant placement |
| Implant Survival | Implant survival at 12 months after implant loading | 12 months after implant loading |
| Santiago de Compostela |
| Spain |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Implants |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Smoking status (never, past, current) | Count of Participants | Participants | Participants |
|
| Number of missing teeth | Mean | Standard Deviation | Teeth | Participants |
|
| Number of Implants | Mean | Standard Deviation | Implants | Implants |
|
| Number of planned implants | Mean | Standard Deviation | Implants | Implants |
|
| OG001 | 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. |
|
|
|
| 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 | The SAF populations defined as all patients who were enrolled in the study and who received a study device | Posted | Number | events | 12 months after implant loading |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | picograms per milliliter | At implant placement, 1 and 4 weeks after implant placement |
|
|
|
| Secondary | Change in Osseointegration Biomarkers Concentrations | Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples. | 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. | Posted | Mean | Standard Deviation | picograms per milliliter | 1, 2, 4 and 8 weeks after implant placement |
|
|
|
| Secondary | Implant Survival | Implant survival at 12 months after implant loading | 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 | Posted | Number | number of lost implants | 12 months after implant loading |
|
|
|
| 0 |
| 68 |
| 2 |
| 68 |
| 26 |
| 68 |
| EG001 | 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. | 0 | 68 | 2 | 68 | 26 | 68 |
| Hernia | Nervous system disorders | Systematic Assessment |
|
|
| Biological Complications | General disorders | Systematic Assessment | Including bruising, local irritation and pain |
|
| Other complications | General disorders | Systematic Assessment | Including facial traumatism, loss of composite covering the crown, and transitory dizziness/nausea during procedure |
|
| Biological Complications - hard tissue related | Musculoskeletal and connective tissue disorders | Systematic Assessment | Including Early Loss/Failure Of Implant (I.E. Before Osseointegration); Implant Mobility (Tactile Horizontal Or Vertical; Late Loss/Failure Of Implant (I.E. After Osseointegration); Low Primary Stability (At Surgery) |
|
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| Inflammation (IL-1B) at implant placement |
|
| Inflammation (IL-1B) at Week 4 |
|
| Inflammation (TNF-a) at implant placement |
|
| Inflammation (TNF-a) at Week 4 |
|
| Inflammation (IL-2) at implant placement |
|
| Inflammation (IL-2) at Week 1 |
|
| Anti-inflammation (IL-10) at implant placement |
|
| Anti-inflammation (IL-10) at Week 4 |
|
| Anti-inflammation (IL-4) at implant placement |
|
| Anti-inflammation (IL-4) at Week 4 |
|
| OCN at implant placement |
|
| OCN at 8 weeks |
|
| OPN at implant placement |
|
| OPN at 8 weeks |
|