N/A
N=38
Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use
Partial Edentulism · Complete Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT02180230 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Marginal Bone Remodeling — -1.34; -1.38; -1.37; -1.65 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Shorty implants (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nobel Biocare
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Marginal Bone Remodeling |
-1.34; -1.38; -1.37; -1.65 | — |
| SECONDARY Cumulative Survival Rates of the Implants |
96.5; 97.7; 98.8; 98.8 | — |
Summary
The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and Brånemark System Mk III Shorty: by determining the marginal bone remodeling, implant survival rate, soft tissue health and maintenance.
Eligibility Criteria
Inclusion Criteria
- The subjects should have an osseous architecture enough to receive an implant with a diameter of at least 3.75 mm for Brånemark System Mk III Shorty or 4 mm for NobelSpeedy Shorty and a sufficient amount of bone for placing implants with a length of 7 mm.
- The final tightening torque at installation should be 35-45 Ncm without further rotation and should not exceed 45 Ncm.
- The subject as well as the implant site(s) should fulfill criteria for immediate provizionalization.
- Immediate insertion (e.g. placement of the implant immediately after extraction) will not constitute an exclusion criterion.
- The implants site(s) should be free from extraction remnants.
- The subject should be healthy and compliant with good oral hygiene.
- The subject should be available for the 5-year term of the investigation.
- Favorable and stable occlusal relationship
Exclusion Criteria
- Alcohol or drug abuse as noted in patient records or in patient history.
- Health conditions, which do not permit the surgical procedure.
- Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in patient records or in patient history.
- The subject is not able to give her/his informed consent to participate.
- Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
- Severe bruxism or other destructive habits.
Data sourced from ClinicalTrials.gov (NCT02180230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.