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Patients with an edentulous mandible restored with implants who have participated in the core study CR 04/07 will be recruited for this extension study. No further interventions will be made for this extension study other than a clinical follow-up examination and questionnaires. Patients will not receive an investigational treatment in this study. Patients will be followed at 5 to 10 years from the date of the original implant loading
The primary study objective is to compare implant survival with the Titanium Zirconium (Roxolid™) implant compared the Titanium grade IV (SLActive®) implant between baseline (surgery) and 10 years.
The following outcome parameters will be evaluated at 5 and 10 years post surgery for the two different implant types Straumann® Bone Level SLActive, diameter 3.3 mm, Titanium-Zirconium (Roxolid®) vs. Straumann® Bone Level SLActive implant, diameter 3.3 mm, Titanium Grade IV:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roxolid | Patient do not receive an intervention in the extension study. Rather they are followed on the implant treatment from the core study which included a split-mouth design where all patients received both a Roxolid and SLActive implant. | ||
| SLActive | Patient do not receive an intervention in the extension study. Rather they are followed on the implant treatment from the core study which included a split-mouth design where all patients received both a Roxolid and SLActive implant. |
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| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival | This is a long term follow up extension study including evaluations at 5 and 10 years after the implant procedure from the core study. Implant survival will be assessed based on surviving implants for all patients at 10 years. | 10 years following implant procedure date |
| Measure | Description | Time Frame |
|---|---|---|
| Crestal bone level change | The change in crestal bone level will be measured on standard x-rays taken at 5 and 10 years as per standard of care. An independent reviewer will evaluate all x-rays for the analysis. | 5 and 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female patient ≥ 18 years of age who were provided with an implant supported over-denture in the mandible in the course of the core study (CR 04/07).
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| Name | Affiliation | Role |
|---|---|---|
| Frauke Müller, Prof. | University of Geneva, Switzerland | Study Chair |
| Bilal Al-Nawas, Prof. | Klinikum der Johannes - Gutenberg - Universität Mainz | Principal Investigator |
| Eugenio Romeo, Prof. | Università degli Studi di Milano, Dipartimento di Medicina, Chirurgia e Odontoiatria | Principal Investigator |
| Joke Duyck, Prof. | Department of Oral Health Sciences, Catholic University (KU) Leuven | Principal Investigator |
| Torsten E Reichert, Prof. | Klinikum der Universität Regensburg | Principal Investigator |
| Alessandro Perucchi, Prof. | Luzerner Kantonsspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frauke Müller | Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37942666 | Derived | Muller F, Al-Nawas B, Storelli S, Quirynen M, Hicklin S, Castro-Laza J, Bassetti M, Srinivasan M; Roxolid Study Group. Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: Ten-year results from a double-blind, randomised controlled split-mouth core-trial. Clin Oral Implants Res. 2024 Jan;35(1):77-88. doi: 10.1111/clr.14199. Epub 2023 Nov 9. | |
| 26458813 |
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
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| Derived |
| Muller F, Al-Nawas B, Storelli S, Quirynen M, Hicklin S, Castro-Laza J, Bassetti R, Schimmel M; Roxolid Study Group. Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: five-year results from a double-blind, randomized controlled trial. BMC Oral Health. 2015 Oct 12;15(1):123. doi: 10.1186/s12903-015-0107-6. |
| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |