A Clinical Evaluation of NobelProcera Implant Bar Overdenture

Study centers: 8 centers in 4 countries

Objectives of the study:

Primary Objective:

To evaluate and compare the clinical marginal bone level change (MBL) around the
NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture
(fixed-removable) in the mandible with the clinical marginal bone level change (MBL) of the
NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture
(fixed-removable) in the maxilla for a period of 5 years.

Secondary Objectives:

1. To evaluate and compare the cumulative survival rate (CSR) of the NobelReplaceTM CC
implants supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the
mandible with the cumulative survival rate (CSR) of the NobelReplaceTM CC implants
supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the maxilla for
a period of 5 years.

2. To evaluate and compare the cumulative survival rate (CSR) of NobelProceraTM Implant
Bar Overdenture (fixed-removable) on four (4) NobelReplace CC implants in the mandible
with the cumulative survival rate (CSR) of NobelProceraTM Implant Bar Overdenture
(fixed-removable) on four (4) NobelReplace CC implants in the maxilla after 5 years.

3. To evaluate the clinical behaviour (soft tissue behavior, clinical function, patient
satisfaction, Quality of Life and prosthetic maintenance needs such as wear, chipping
of denture teeth, need for exchange of attachment components) of NobelProceraTM Implant
Bar Overdenture (fixed-removable) in the mandible and maxilla over 5 years of clinical
function.

Study design 5-year, open, prospective, clinical multi-center study.

Number of subjects 76 (in total), 7-9 per center

Patient population Adult female or male, at least 18 (or age of consent) and not older than
70 years, suitable for treatment with implant supported bar overdentures in the edentulous
mandible or maxilla.

Inclusion Criteria:

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

2. The subject is not older than 70 years

3. Obtained informed consent from the subject

4. Edentulous mandible or maxilla providing sufficient bone whereas removable
NobelProceraTM Implant Bar Overdenture on four (4) implants is regarded as an
appropriate treatment solution

5. The subject has an osseous architecture enough to receive four implants and a
sufficient amount of bone for placing in healed or extraction sites implants with a
length of at least 10mm

6. The implant site is free from infection and extraction remnants

7. Implants will be placed in healed or extractions sites, defined as a site with 8
weeks of healing following tooth extraction, respectively 6 months after major bone
augmentation or soft tissue grafting

8. Good gingival / periodontal / periapical status of opposing teeth/implants

9. 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

10. The subjects as well as the implant site(s) fulfill the criteria for early loading (6
weeks until 3 months after implant placement)

11. The subject is in such a physical and mental condition that a 5-year follow-up period
can be carried out without foreseeable problems

12. The subject is available for the 5-year term of the investigation

13. The subject is compliant with good oral hygiene

Exclusion Criteria:

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

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

3. 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

4. Any disorders in the planned implant area such as previous tumors, chronic bone
disease or previous irradiation in the head/neck area

5. Alcohol or drug abuse as noted in subject records or in subject history

6. Smoking of >10 cigarettes/day

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

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

9. Lack of opposing dentition or unstable occlusion

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

11. Subject shows an unacceptable oral hygiene

12. Subject has allergic or adverse reactions to the restorative material.

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

14. Long-term bis-phosphonate therapy