Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration Clinical Trial
Official title:
A 5-year Clinical Evaluation on Brånemark System® RP Ø4.5x4.5 mm Implants
| Verified date | June 2014 |
| Source | Nobel Biocare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 144 |
| Est. completion date | August 2019 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Universitätsmedizin Mainz | Mainz | |
| Germany | Universtätsmedizin Mainz | Mainz | Rhl-Palat. |
| Lead Sponsor | Collaborator |
|---|---|
| Nobel Biocare |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | difference between maxilla and mandible | yearly, up to 5 years | ||
| Primary | marginal bone level changes | yearly, up to 5 years | ||
| Secondary | cumulative survival and success rates | yearly, up to 5 years |