All-On-4® Treatment Concept

Not Applicable

Terminated

• Conditions: Edentulous
• Interventions: Device: Nobel Active, Nobel Procera IBO

• Registration Number: NCT02186912
• Lead Sponsor: Nobel Biocare

Brief Summary

Indication : edentulous patients To evaluate and compare the marginal bone level change around tilted and straight NobelActive implants placed in healed sites with All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge (fixed) in the mandible and maxilla.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

The subject is not able to give her/his informed consent of participating

Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure

Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area

Alcohol or drug abuse as noted in subject records or in subject history Smoking of >10 cigarettes/day

Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake

Pathologic occlusion, e.g. severe bruxism or other destructive habits

Lack of opposing dentition or unstable occlusion

Ongoing infections, endodontic or periodontal problems in opposing teeth or implants

Subject shows an unacceptable oral hygiene

Subject has allergic or adverse reactions to the restorative material.

Bone augmentation of more than 3mm vertical height performed less than 6 months prior to planned implant placement.

Bis-phosphonate therapy

Implant insertion torque is <35 Ncm or >70 Ncm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
maxilla	Nobel Active, Nobel Procera IBO	Nobel Active Nobel Procera IBO
mandible	Nobel Active, Nobel Procera IBO	Nobel Active Nobel Procera IBO

Primary Outcome Measures

Name	Time	Method
bone level change around tilted and straight implants	yearly up to 5 years

Secondary Outcome Measures

Name	Time	Method
cumulative survival rate (CSR)	yearly up to 5 years

Trial Locations

Locations (1)

Universitätsmedizin Mainz; 🇩🇪 Mainz, Rheinland-Pfalz, Germany