Study Results
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Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2016-08-31
2025-11-13
Brief Summary
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Detailed Description
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Roxolid Standard Plus Implants, 4 mm, Ø 4.1 mm, SLActive will be placed in positions 36/46 or 35/45, 36/46.
Roxolid Standard Plus Implants, Ø 4.1 mm, SLActive, in lengths of 10, 12 and 14 mm will be placed in positions 33/43.
In total 10 visits per patient are scheduled in this study. Implant survival, implant success, prosthetic survival and success, and adverse events (AEs) will be assessed.
All products are CE-(Conformité Européenne, meaning European Conformity) marked and used within its intended use.
Two centers in Switzerland and Northern Ireland will participate. The study and any amendments will be performed according to International Organization for Standardization (ISO) 14155:2011, local legal and regulatory requirements and conform to the Declaration of Helsinki (last revision Fortaleza 2013)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Roxolid short implant, 4 mm length (4)
Straumann Tissue Level Ø4.1 mm RN SLActive Roxolid Standard Plus Implants available in lengths 4mm, 10mm, 12mm and 14mm
Roxolid short implant, 4 mm length (4)
Placement of a combination of four short implants (in positions 35/45, 36/46) as distal support and two implants of conventional length (in positions 33/43) in the interforaminal region, in order to support a cross-arch fixed screw-retained prosthesis.
Roxolid short implant, 4 mm length (2)
Straumann Tissue Level Ø4.1 mm RN SLActive Roxolid Standard Plus Implants available in lengths 4mm, 10mm, 12mm and 14mm
Roxolid short implant, 4 mm length (2)
Placement of a combination of two short implants (in positions 36/46) as distal support and two implants of conventional length (in positions 33/43) in the interforaminal region, in order to support a cross-arch fixed screw-retained prosthesis.
Interventions
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Roxolid short implant, 4 mm length (4)
Placement of a combination of four short implants (in positions 35/45, 36/46) as distal support and two implants of conventional length (in positions 33/43) in the interforaminal region, in order to support a cross-arch fixed screw-retained prosthesis.
Roxolid short implant, 4 mm length (2)
Placement of a combination of two short implants (in positions 36/46) as distal support and two implants of conventional length (in positions 33/43) in the interforaminal region, in order to support a cross-arch fixed screw-retained prosthesis.
Eligibility Criteria
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Inclusion Criteria
* Subject must have voluntarily signed the informed consent, are willing and able to attend scheduled follow-up visits, and agree that the encoded data will be collected and analyzed
* Fully edentulous (latest extraction in the mandible should be performed at least 12 weeks before implant placement) that can be restored with a complete denture
* Atrophic jaw bone in the posterior area, sufficient bone height and width to permit insertion of four short implants, 4 mm in regions of the first molar and second premolar on both sides and two standard length implants in the canine region
Exclusion Criteria
* Uncontrolled systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
* Any contraindications for oral surgical procedures
* History of local irradiation therapy in the head / neck area
* Patients who smoke \>10 cigarettes per day or tobacco equivalents, chew tobacco or have ≥ 20 pack years
* Medical conditions requiring chronic high dose steroid therapy or high dose anti-resorptive treatment
* Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study
* 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
* Cognitive impairment that would interfere with the ability to perform adequate oral hygiene (assessed by the Ottawa 3DY scale)
* Patients with chronic pain
* Patients with HIV and/ or Hepatitis infection
* Severe bruxing or clenching habits
* Patients with inadequate oral hygiene or unmotivated for adequate home care (Denture Plaque Index (DPI) ≥ 5)
* Patients with drug or alcohol abuse
* Patients with allergies or hypersensitivity to chemical ingredients of titanium-zirconium alloy
* Major simultaneous augmentation procedures. Dehiscence of a vertical distance of more than 3 mm
* A woman who is pregnant or planning to become pregnant at any point during the study duration
* Patients with inadequate bone volume and/or quality
18 Years
ALL
No
Sponsors
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Institut Straumann AG
INDUSTRY
Responsible Party
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Principal Investigators
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Julia-Gabriela Wittneben, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Bern, Department of Reconstructive Dentistry and Gerodontology
Locations
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University of Bern, Department of Reconstructive Dentistry and Gerodontology
Bern, , Switzerland
Queens University Belfast, School of Medecine, Dentistry and Biomedical Sciences
Belfast, , United Kingdom
Countries
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References
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Muller F, Hernandez M, Grutter L, Aracil-Kessler L, Weingart D, Schimmel M. Masseter muscle thickness, chewing efficiency and bite force in edentulous patients with fixed and removable implant-supported prostheses: a cross-sectional multicenter study. Clin Oral Implants Res. 2012 Feb;23(2):144-150. doi: 10.1111/j.1600-0501.2011.02213.x. Epub 2011 Jun 2.
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Slotte C, Gronningsaeter A, Halmoy AM, Ohrnell LO, Mordenfeld A, Isaksson S, Johansson LA. Four-Millimeter-Long Posterior-Mandible Implants: 5-Year Outcomes of a Prospective Multicenter Study. Clin Implant Dent Relat Res. 2015 Oct;17 Suppl 2:e385-95. doi: 10.1111/cid.12252. Epub 2014 Jul 17.
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Other Identifiers
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CR 03/15
Identifier Type: -
Identifier Source: org_study_id
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