Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration
Conditions
Keywords
short implants, Nobel Biocare, partially edentulous, maxilla or mandible
Brief summary
An extra short, 2-piece implant with a Brånemark hexagon interface was developed with a bone anchoring length of only 4.5 mm, for subjects with severely resorbed jaws.
Interventions
DEVICEextra short implant
Sponsors
Nobel Biocare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The subject should be at least 18 years of age and have passed secession of growth * The subject should be in need of an implant-supported restoration in the posterior region of the mouth (maxilla: first premolar to third molar, mandible: first premolar to second molar, not third molar due to mobile gingiva), where at least 2 implants are needed of which at least one should be an Extra Short Implant * Obtained informed consent from the subject * The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems * The subject should have a severely resorbed posterior mandible and/ or maxilla. * Implants are only to be placed in healed sites, defined as a site with minimum 6 months of healing following tooth extraction * At least 6 mm residual bone width, between 4-7 mm residual bone height in the maxilla and between 6-9 mm residual bone height in the mandible * At implant installation the implant should be stable; final tightening torque of the implant about 25 Ncm or higher, preferably not exceeding 45 Ncm * The subject should be healthy and compliant with good oral hygiene * Favorable and stable occlusal relationship
Exclusion criteria
* The subject is not able to give her/his informed consent of participating * Health conditions, which do not permit the surgical treatment * Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in subject records or in subject history * Any disorders in the planned implant area such as previous tumours, chronic bone disease or previous irradiation * Alcohol or drug abuse as noted in subject records or in subject history. * Heavy smoking (\>10 cigarettes/day) * Intake of medication containing bisphosphonates * Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake * Severe bruxism or other destructive habits * Immediate insertion (i.e. placement of the implant immediately after extraction) * Bone augmentation procedures before or at implant installation is not allowed * Deviation from stated drilling protocol, utilizing osteotomes, is not allowed * Lack of opposing dentition * Single crown restorations are not to be performed in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| marginal bone level changes | yearly, up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| cumulative survival and success rates | yearly, up to 5 years |
Other
| Measure | Time frame |
|---|---|
| difference between maxilla and mandible | yearly, up to 5 years |
Countries
Germany
Outcome results
None listed