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

A 5-year Clinical Evaluation on Brånemark System® RP Ø4.5x4.5 mm Implants

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration
• Intervention / Treatment: Device: extra short implant

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55131
    • Universitätsmedizin Mainz
  • Rhl-Palat.
    • Mainz, Rhl-Palat., Germany, 55131
      • Universtätsmedizin Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: short implants	Device: extra short implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
marginal bone level changes	yearly, up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
cumulative survival and success rates	yearly, up to 5 years

Other Outcome Measures

Outcome Measure	Time Frame
difference between maxilla and mandible	yearly, up to 5 years

Collaborators and Investigators

• Sponsor: Nobel Biocare

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: June 30, 2014
• First Posted (Estimate): July 1, 2014

Study Record Updates

• Last Update Posted (Estimate): July 1, 2014
• Last Update Submitted That Met QC Criteria: June 30, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: short implants; Nobel Biocare; partially edentulous; maxilla or mandible
• Other Study ID Numbers: T-163

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No