A Clinical Evaluation of NobelProcera Implant Bar Overdenture

NCT ID: NCT01720420

Last Updated: 2018-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2020-12-31

Brief Summary

AN OPEN 5-YEAR PROSPECTIVE, CLINICAL MULTI-CENTER STUDY on NobelProcera Implant Bar Titanium with Locator attachment and related Overdenture on 4 NobelReplace implants with conical connection (CC) in the mandible/maxilla.

Detailed Description

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.

Conditions

Edentulous

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mandible

NobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)

Group Type: EXPERIMENTAL

NobelReplace CC, NobelProcera Implant Bar

Intervention Type: DEVICE

Implants titanium with conical connection, individualized titanium bar

Maxilla

NobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)

Group Type: EXPERIMENTAL

NobelReplace CC, NobelProcera Implant Bar

Intervention Type: DEVICE

Implants titanium with conical connection, individualized titanium bar

Interventions

NobelReplace CC, NobelProcera Implant Bar

Implants titanium with conical connection, individualized titanium bar

Intervention Type: DEVICE

Other Intervention Names

NobelReplace CC implants; NobelProcera Implant Bar Titanium; Overdenture (lab-made)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Nobel Biocare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guido Heydecke, Prof

Role: PRINCIPAL_INVESTIGATOR

Poliklinik für Zahnärztliche Prothetik, University Hamburg

Alessandro Pozzi, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Rome, Italy

Eugenio Romeo, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Milan, Italy

Marco Ferrari, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Siena, Italy

Edoardo Stellini, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Padova, Italy

Nikolaus and Alexandra Behneke, Prof., Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Mainz, Germany

Silvio Meloni, Dr.

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Sassari

Locations

Guido Heydecke

Hamburg, , Germany

Nikolaus and Alexandra Behneke

Mainz, , Germany

Eugenio Romeo

Milan, , Italy

Edoardo Stellini

Padua, , Italy

Alessandro Pozzi

Rome, , Italy

Università degli Studi di Sassari

Sassari, , Italy

Marco Ferrari

Siena, , Italy

Countries

Germany; Italy

Other Identifiers

T-174

Identifier Type: -

Identifier Source: org_study_id