This trial is active, not recruiting.

Condition healthy volunteers with severely resorbed jaws in need of an implant supported restoration
Treatment extra short implant
Sponsor Nobel Biocare
Start date January 2010
End date December 2018
Trial size 144 participants
Trial identifier NCT02178891, T-163


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
extra short implant

Primary Outcomes

marginal bone level changes
time frame: yearly, up to 5 years

Secondary Outcomes

cumulative survival and success rates
time frame: yearly, up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A 5-year Clinical Evaluation on Brånemark System® RP Ø4.5x4.5 mm Implants
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Nobel Biocare.