This trial is active, not recruiting.

Condition patients with good quality bone, missing at least one tooth in the upper or lower jaw.
Treatments nobelspeedy shorty implant, brånemark system mk iii shorty implants
Sponsor Nobel Biocare
Start date October 2007
End date May 2015
Trial size 53 participants
Trial identifier NCT02180230, T-127


Surgical and restorative procedures in the posterior region of both the mandible and the maxilla present a complex task. The posterior regions usually exhibit less favorable bone quality and less bone volume, while they are exposed to greater loads than anterior regions of the mouth. Thus short implants (i.e. ≤10 mm) are best to use, which creates a dilemma, since short implants historically have been associated with higher failure rates than longer implants. However, no direct correlation between implant length and stability, anchorage or bone stress, have been demonstrated. Instead poor bone quality is likely the most significant factor associated with short implant failure.

Development of implant design, surface structure and improved surgical technique have proven short implants to be a viable concept with survival rates comparable to longer implants.

The aim of the study is to evaluate marginal bone level and soft tissue response over time, around immediately loaded NobelSpeedyTM Shorty and Brånemark System® Mk III Shorty implants in daily use.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Speedy design
nobelspeedy shorty implant
brånemark system mk iii shorty implants
Branemark implant designe
nobelspeedy shorty implant
brånemark system mk iii shorty implants

Primary Outcomes

Marginal bone level
time frame: yearly from baseline up to 5 years

Secondary Outcomes

Soft tissue Health including papilla index and periimplant mucosa
time frame: yearly from baseline up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - The subjects should have an osseous architecture enough to receive an implant with a diameter of at least 3.75 mm for Brånemark System Mk III Shorty or 4 mm for NobelSpeedy Shorty and a sufficient amount of bone for placing implants with a length of 7 mm. - The final tightening torque at installation should be 35-45 Ncm without further rotation and should not exceed 45 Ncm. - The subject as well as the implant site(s) should fulfill criteria for immediate provizionalization. - Immediate insertion (e.g. placement of the implant immediately after extraction) will not constitute an exclusion criterion. - The implants site(s) should be free from extraction remnants. - The subject should be healthy and compliant with good oral hygiene. - The subject should be available for the 5-year term of the investigation. - Favorable and stable occlusal relationship Exclusion Criteria: - Alcohol or drug abuse as noted in patient records or in patient history. - Health conditions, which do not permit the surgical procedure. - Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in patient records or in patient history. - The subject is not able to give her/his informed consent to participate. - Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation. - Severe bruxism or other destructive habits.

Additional Information

Official title Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Nobel Biocare.