Clinical trial NCT02178891: Extra Short Implants Brånemark System® RP Ø4.5x4.5 mm Implants
Official title: A 5-year Clinical Evaluation on Brånemark System® RP Ø4.5x4.5 mm Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration
Keywords: short implants
Nobel Biocare
partially edentulous
maxilla or mandible
Lead sponsor: Nobel Biocare
Sponsor class: INDUSTRY
First posted: 2014-07-01
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: marginal bone level changes
timeFrame: yearly, up to 5 years
Secondary outcomes:
measure: cumulative survival and success rates
timeFrame: yearly, up to 5 years
Other outcomes:
measure: difference between maxilla and mandible
timeFrame: yearly, up to 5 years
Locations:
city: Mainz
country: Germany
facility: Universtätsmedizin Mainz
state: Rhl-Palat.
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
Study officials:
References: