An interventional study of Roxolid short implant, 4 mm length (4) and Roxolid short implant, 4 mm length (2) in Jaw Edentulous, sponsored by Institut Straumann AG. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Institut Straumann AG · Not applicable, Interventional, and Other
This study aims to compare the clinical performance of 4 mm short implants supporting cross-arch fixed reconstructions in the edentulous mandible either with a combination of two short implants as distal support and two implants of conventional length placed in the interforaminal region, or with a combination of four short implants as distal support and two interforaminal implants of conventional length.
This is a post-market, multi-center, prospective, open, randomized controlled clinical study. The total study duration for each patient should be 36 ± 2 months.
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)
171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.
This study's enrollment of 53 is above the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.
Browse Jaw, Edentulous studies →Institut Straumann AG is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Secondary Exclusion Criteria:
Straumann Tissue Level Ø4.1 mm RN SLActive Roxolid Standard Plus Implants available in lengths 4mm, 10mm, 12mm and 14mm
Device: 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
Device: Roxolid short implant, 4 mm length (2)
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.
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.
Implant survival
A surviving implant is defined as an implant in place at the time of the follow-up. Any implant loss shall be assessed as an early loss (implant fails before being osseointegrated) or late loss (after being osseointegrated)
Time frame: 12 months after baseline
Implant success will be evaluated according to Buser
A particular implant will be considered successful if all of the following success criteria according to Buser et al. (Buser et al. 1991) apply: * Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation) * Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if observed at two or more follow-up visits after the treatment with systemic antibiotics) * Absence of implant mobility on manual palpation * Absence of any continuous peri-implant radiolucency
Time frame: 12 and 36 months after baseline
Prosthetic survival & success
During the prosthodontic examination, the implant supported prostheses will be examined for any complications and failures as adapted from the ITI Treatment Guide Volume 8 (Brägger \& Heitz-Mayfield 2015)
Time frame: 12 and 36 months after baseline
Crestal bone level change at the implant site (mesial and distal)
Mesial and distal implant bone levels will be evaluated on a panoramic radiograph at baseline, 12 and 36 months after implant loading
Time frame: 12 and 36 months after baseline
Implant survival
A surviving implant is defined as an implant in place at the time of the follow-up. Any implant loss shall be assessed as an early loss (implant fails before being osseointegrated) or late loss (after being osseointegrated)
Time frame: 36 months after baseline
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Institut Straumann AG