All-On-4® Treatment Concept

Edentulous Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02186912
• Other study ID #: T-185
• Status: Terminated
• Phase: N/A
• First received: July 8, 2014
• Last updated: April 4, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Nobel Biocare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionAustria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edentulous
• Mouth, Edentulous

Intervention

Device:
• Nobel Active, Nobel Procera IBO

Locations

Country	Name	City	State
Germany	Universitätsmedizin Mainz	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Nobel Biocare

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life		yearly up to 5 years	No
Primary	bone level change around tilted and straight implants		yearly up to 5 years	Yes
Secondary	cumulative survival rate (CSR)		yearly up to 5 years	Yes