Clinical trial NCT01720420: A Clinical Evaluation of NobelProcera Implant Bar Overdenture
Official title: A Clinical Evaluation of NobelProceraTM Implant Bar Overdenture in the Mandible or Maxilla on 4 NobelReplaceTM CC Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous
Keywords: edentulous
maxilla
mandible
dental implant
bar
overdenture
Oral Health Impact Profile (OHIP)
survival rate
technical complications
marginal bone level
soft tissue
Lead sponsor: Nobel Biocare
Sponsor class: INDUSTRY
Collaborators: name: Charite University, Berlin, Germany
First posted: 2012-11-02
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MBL,marginal bone level change
timeFrame: 6 month, 1, 2, 3, 5 year
Secondary outcomes:
measure: CSR implants
timeFrame: 6 month, 1, 2, 3, 5 year
measure: CSR prosthetics
timeFrame: 6 month, 1, 2, 3, 5 year
measure: Gingival Status
timeFrame: 6 month, 1, 2, 3, 5 year
measure: Status of mucosa
timeFrame: 6 month, 1, 2, 3, 5 year,
measure: Bleeding tendency
timeFrame: 6 month, 1, 2, 3, 5 year
measure: plaque accumulation
timeFrame: 6 month, 1, 2, 3, 5 year
measure: Pocket depths
timeFrame: 6 month, 1, 2, 3, 5 year
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Guido Heydecke
city: Mainz
country: Germany
facility: Nikolaus and Alexandra Behneke
city: Milan
country: Italy
facility: Eugenio Romeo
city: Padova
country: Italy
facility: Edoardo Stellini
city: Rome
country: Italy
facility: Alessandro Pozzi
city: Sassari
country: Italy
facility: Università degli Studi di Sassari
city: Siena
country: Italy
facility: Marco Ferrari
Study officials:
affiliation: Poliklinik für Zahnärztliche Prothetik, University Hamburg
name: Guido Heydecke, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rome, Italy
name: Alessandro Pozzi, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Milan, Italy
name: Eugenio Romeo, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Siena, Italy
name: Marco Ferrari, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Padova, Italy
name: Edoardo Stellini, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mainz, Germany
name: Nikolaus and Alexandra Behneke, Prof., Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Sassari
name: Silvio Meloni, Dr.
role: PRINCIPAL_INVESTIGATOR
References: