Extra Short Implants Brånemark System® RP Ø4.5x4.5 mm Implants

Nobel Biocare

Status

Unknown

Conditions

Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration

Treatments

Device: extra short implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT02178891

T-163

Details and patient eligibility

About

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.

Enrollment

144 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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