A Clinical Evaluation of NobelProcera Implant Bar Overdenture

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Nobel Biocare
Sponsor:
Collaborator:
Dr. Martin Vanselow Biometrie & Statistik
Information provided by (Responsible Party):
Nobel Biocare
ClinicalTrials.gov Identifier:
NCT01720420
First received: October 22, 2012
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Edentulous
Device: NobelReplace CC, NobelProcera Implant Bar

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of NobelProceraTM Implant Bar Overdenture in the Mandible or Maxilla on 4 NobelReplaceTM CC Implants

Further study details as provided by Nobel Biocare:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 76
Study Start Date: October 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mandible
NobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)
Device: NobelReplace CC, NobelProcera Implant Bar
Implants titanium with conical connection, individualized titanium bar
Other Names:
  • NobelReplace CC implants
  • NobelProcera Implant Bar Titanium
  • Overdenture (lab-made)
Experimental: Maxilla
NobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)
Device: NobelReplace CC, NobelProcera Implant Bar
Implants titanium with conical connection, individualized titanium bar
Other Names:
  • NobelReplace CC implants
  • NobelProcera Implant Bar Titanium
  • Overdenture (lab-made)

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720420

Contacts
Contact: Katrin-Caroline Voigt +41432115 ext 840 katrin.caroline.voigt@nobelbiocare.com

Locations
United States, Tennessee
Paprocki Gergory Recruiting
Memphis, Tennessee, United States, 38163
Contact: Gregory Paprocki, Prof    901-448-6642    gpaprock@uthsc.edu   
Principal Investigator: Gergory Paprocky, Prof         
Germany
Guido Heydecke Recruiting
Hamburg, Germany, 20246
Contact: Guido Heydecke, Prof    +4940741053267    g.heydecke@uke.de   
Principal Investigator: Guido Heydecke, Prof         
Nikolaus and Alexandra Behneke Recruiting
Mainz, Germany, 55131
Contact: Alexandra Behneke, Dr.    +49613117 ext 7257    alexandra.behneke@unimedizin-mainz.de   
Contact: Nikolaus Behneke, Prof    +49613117 ext 7257    nbehneke@unimedizin-mainz.de   
Principal Investigator: Nikolaus Behneke, Prof         
Sub-Investigator: Alexandra Behneke, Dr         
Italy
Eugenio Romeo Recruiting
Milan, Italy, 20143
Contact: Eugenio Romeo, Prof    +3925319004    eugenio.romeo@unimi.it   
Principal Investigator: Eugenio Romeo, Prof         
Gianantonio Favero Recruiting
Padova, Italy, 35128
Contact: Gianantonio Favero, Prof    +39335284956    gafavero@tin.it   
Principal Investigator: Gianantonio Favero, Prof         
Alessandro Pozzi Recruiting
Rome, Italy, 00133
Contact: Alessandro Pozzi, Prof    +39337871240    studiopozzi@me.com   
Principal Investigator: Alessandro Pozzi, Prof         
Marco Ferrari Recruiting
Siena, Italy, 53100
Contact: Marco Ferrari, Prof    +39586892283    md3972@mclink.it   
Principal Investigator: Marco Ferrari, Prof         
Sponsors and Collaborators
Nobel Biocare
Dr. Martin Vanselow Biometrie & Statistik
Investigators
Principal Investigator: Guido Heydecke, Prof Poliklinik für Zahnärztliche Prothetik, University Hamburg
Principal Investigator: Regina Mericske-Stern, Prof University of Bern, Switzerland
Principal Investigator: Alessandro Pozzi, Prof University of Rome, Italy
Principal Investigator: Eugenio Romeo, Prof University of Milan, Italy
Principal Investigator: Marco Ferrari, Prof University of Siena, Italy
Principal Investigator: Gianantonio Favero, Prof University of Padova, Italy
Principal Investigator: Gregory Paprocki, Prof University of Memphis, USA
Principal Investigator: Nikolaus and Alexandra Behneke, Prof., Dr. University of Mainz, Germany
  More Information

No publications provided

Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT01720420     History of Changes
Other Study ID Numbers: T-174
Study First Received: October 22, 2012
Last Updated: June 27, 2014
Health Authority: Germany: Ethics Commission
Switzerland: Ethikkommission
Italy: Ethics Committee
United States: Institutional Review Board

Keywords provided by Nobel Biocare:
edentulous
maxilla
mandible
dental implant
bar
overdenture
Oral Health Impact Profile (OHIP)
survival rate
technical complications
marginal bone level
soft tissue

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on July 20, 2014