All-On-4® Treatment Concept

NCT ID: NCT02186912

Last Updated: 2016-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Edentulous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

mandible

Nobel Active Nobel Procera IBO

Group Type EXPERIMENTAL

Nobel Active, Nobel Procera IBO

Intervention Type DEVICE

maxilla

Nobel Active Nobel Procera IBO

Group Type EXPERIMENTAL

Nobel Active, Nobel Procera IBO

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nobel Active, Nobel Procera IBO

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nobel Active implants Implant bar

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nobel Biocare

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

T-185

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

NobelProceraTM Bridge Shaded Zirconia
NCT02197312 TERMINATED NA