Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use

NCT ID: NCT02180230

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2014-12-31

Brief Summary

The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and Brånemark System Mk III Shorty: by determining the marginal bone remodeling, implant survival rate, soft tissue health and maintenance.

Detailed Description

The primary endpoint was the change in marginal bone levels (in mm) from the time of implant insertion to follow-up visits (3, 6, 12, 36 and 60 months).

Further endpoints were:

• cumulative survival rates of the implants
• soft tissue parameters (papilla index, bleeding on probing)
• plaque formation

Conditions

Partial Edentulism; Complete Edentulism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Shorty implants

Brånemark System Mk III Shorty and/or NobelSpeedy Shorty

Group Type: OTHER

Shorty implants

Intervention Type: DEVICE

Dental implant insertion to maxilla or mandible

Interventions

Shorty implants

Dental implant insertion to maxilla or mandible

Intervention Type: DEVICE

Other Intervention Names

Brånemark System Mk III Shorty and/or NobelSpeedy Shorty

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nobel Biocare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

T-127

Identifier Type: -

Identifier Source: org_study_id