All-On-4® Treatment Concept

NCT02186912 | Terminated

• 1 other identifier: T-185
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous

Keywords

edentulous; Nobel Active; Nobel Procera; IBO; CAD/CAM

Outcome Measures

Primary Outcomes (1)

• bone level change around tilted and straight implants

  yearly up to 5 years

Secondary Outcomes (1)

• cumulative survival rate (CSR)

  yearly up to 5 years

Other Outcomes (1)

• Quality of Life

  yearly up to 5 years

Study Arms (2)

mandible

EXPERIMENTAL

Nobel Active Nobel Procera IBO

Device: Nobel Active, Nobel Procera IBO

maxilla

EXPERIMENTAL

Nobel Active Nobel Procera IBO

Device: Nobel Active, Nobel Procera IBO

Interventions

Nobel Active, Nobel Procera IBO DEVICE

Also known as: Nobel Active implants, Implant bar

mandible; maxilla

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nobel Biocare: lead

Study Sites (1)

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 10, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

DE (1)