A Clinical Evaluation of NobelProcera Implant Bar Overdenture

• MBL,marginal bone level change [ Time Frame: 6 month, 1, 2, 3, 5 year ] [ Designated as safety issue: No ]
  To evaluate and compare the clinical marginal bone level change (change MBL)in relation to defined implant reference point and different time points in the maxilla and mandible(between baseline at implant insertion and follow-up time points at 1 month, 6 month, 1 year, 2 year, 3 year and 5 year after implant insertion) of observation.
  
  

• CSR implants [ Time Frame: 6 month, 1, 2, 3, 5 year ] [ Designated as safety issue: No ]
  CSR in % of placed implants
  
  
• CSR prosthetics [ Time Frame: 6 month, 1, 2, 3, 5 year ] [ Designated as safety issue: No ]
  survival in % of placed final restorations
  
  
• Gingival Status [ Time Frame: 6 month, 1, 2, 3, 5 year ] [ Designated as safety issue: No ]
  Gingival status(Silness and Loe 1963):0 = Normal gingiva surrounding crown/control tooth,1 = Mild inflammation,2 = Moderate inflammation.3 = Severe inflammation.
  
  
• Status of mucosa [ Time Frame: 6 month, 1, 2, 3, 5 year, ] [ Designated as safety issue: No ]
  0 = No keratinized mucosa.1 = Mucosa partially keratinized.2 = entire mucosa keratinized.
  
  
• Bleeding tendency [ Time Frame: 6 month, 1, 2, 3, 5 year ] [ Designated as safety issue: No ]
  (modified Sulcus Bleeding Index_mBI)(Mombelli):0 = No bleeding when a periodontal probe is passed along gingival margin adjacent to the implant.1 = Isolated bleeding spots visible. 2 = Blood forms a confluent red line on the margin 3 = Heavy or profuse bleeding.
  
  
• plaque accumulation [ Time Frame: 6 month, 1, 2, 3, 5 year ] [ Designated as safety issue: No ]
  modified Plaque Index (mPlI) (Mombelli):0 = No detectible plaque. 1 = Plaque only recognized by running a probe across the marginal surface of the implant. 2 = Plaque can be seen by the naked eye.3 = Abundance of soft matter
  
  
• Pocket depths [ Time Frame: 6 month, 1, 2, 3, 5 year ] [ Designated as safety issue: No ]
  Pocket depths measured around implants in millimeter (mm)
  
  

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.