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All-On-4® Treatment Concept

Primary Purpose

Edentulous

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Nobel Active, Nobel Procera IBO

About this trial

This is an interventional treatment trial for Edentulous focused on measuring edentulous, Nobel Active, Nobel Procera, IBO, CAD/CAM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

The subject is at least 18 years of age (or age of consent) and has passed secession of growth

Obtained informed consent from the subject

Edentulous mandible or maxilla providing sufficient bone whereas a fixed NobelProceraTM Implant bridge on four (4) implants is regarded as an appropriate treatment solution

The subject has an osseous architecture enough to receive four implants and a sufficient amount of bone for placing in healed sites implants with a length of at least 8 mm

The implant site is free from infection and extraction remnants Implants will be placed in healed sites.

Good gingival / periodontal / peri-apical status of opposing teeth/implants

The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based

The subjects as well as the implant site(s) fulfill the criteria for immediate loading.

The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems The subject is available for the 5-year term of the investigation

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

Sites / Locations

Universitätsmedizin Mainz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

mandible

maxilla

Arm Description

Nobel Active Nobel Procera IBO

Outcomes

Primary Outcome Measures

bone level change around tilted and straight implants

Secondary Outcome Measures

cumulative survival rate (CSR)

Full Information

NCT ID

NCT02186912

First Posted

July 8, 2014

Last Updated

April 4, 2016

Sponsor

Nobel Biocare

1. Study Identification

Unique Protocol Identification Number

NCT02186912

Brief Title

All-On-4® Treatment Concept

Official Title

A Clinical Evaluation of All-On-4® Treatment Concept in the Mandible or Maxilla on 4 NobelActive®Implants With a Fixed NobelProcera® Implant Bridge

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Terminated

Why Stopped

The study stopped as the performance of the study showed insufficient patient recruitment.

Study Start Date

January 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nobel Biocare

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edentulous

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mandible

Arm Type

Experimental

Arm Description

Nobel Active Nobel Procera IBO

Arm Title

maxilla

Arm Type

Experimental

Arm Description

Nobel Active Nobel Procera IBO

Intervention Type

Device

Intervention Name(s)

Nobel Active, Nobel Procera IBO

Other Intervention Name(s)

Nobel Active implants, Implant bar

Primary Outcome Measure Information:

Title

bone level change around tilted and straight implants

Time Frame

yearly up to 5 years

Secondary Outcome Measure Information:

Title

cumulative survival rate (CSR)

Time Frame

yearly up to 5 years

Other Pre-specified Outcome Measures:

Title

Quality of Life

Time Frame

yearly up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

The subject is at least 18 years of age (or age of consent) and has passed secession of growth Obtained informed consent from the subject Edentulous mandible or maxilla providing sufficient bone whereas a fixed NobelProceraTM Implant bridge on four (4) implants is regarded as an appropriate treatment solution The subject has an osseous architecture enough to receive four implants and a sufficient amount of bone for placing in healed sites implants with a length of at least 8 mm The implant site is free from infection and extraction remnants Implants will be placed in healed sites. Good gingival / periodontal / peri-apical status of opposing teeth/implants The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based The subjects as well as the implant site(s) fulfill the criteria for immediate loading. The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems The subject is available for the 5-year term of the investigation 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

Facility Information:

Facility Name

Universitätsmedizin Mainz

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

12. IPD Sharing Statement

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All-On-4® Treatment Concept

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