A Clinical Evaluation of NobelProcera Implant Bar Overdenture

NCT01720420 | Unknown DMC

• 1 other identifier: T-174
• Study Type: interventional
• Target: 77
• Locations: 2 countries
• Sites: 7

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.

Conditions

Edentulous

Keywords

edentulous; maxilla; mandible; dental implant; bar; overdenture; Oral Health Impact Profile (OHIP); survival rate; technical complications; marginal bone level; soft tissue

Outcome Measures

Primary Outcomes (1)

• MBL,marginal bone level change

  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.

  6 month, 1, 2, 3, 5 year

Secondary Outcomes (7)

• CSR implants

  6 month, 1, 2, 3, 5 year

• CSR prosthetics

  6 month, 1, 2, 3, 5 year

• Gingival Status

  6 month, 1, 2, 3, 5 year

• Status of mucosa

  6 month, 1, 2, 3, 5 year,

• Bleeding tendency

  6 month, 1, 2, 3, 5 year

Study Arms (2)

Mandible

EXPERIMENTAL

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

Device: NobelReplace CC, NobelProcera Implant Bar

Maxilla

EXPERIMENTAL

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

Device: NobelReplace CC, NobelProcera Implant Bar

Interventions

NobelReplace CC, NobelProcera Implant Bar DEVICE

Implants titanium with conical connection, individualized titanium bar

Also known as: NobelReplace CC implants, NobelProcera Implant Bar Titanium, Overdenture (lab-made)

Mandible; Maxilla

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is at least 18 years of age (or age of consent) and has passed secession of growth
• The subject is not older than 70 years
• Obtained informed consent from the subject
• Edentulous mandible or maxilla providing sufficient bone whereas removable NobelProceraTM Implant Bar Overdenture on four (4) implants is regarded as an appropriate treatment solution
• 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
• The implant site is free from infection and extraction remnants
• 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
• Good gingival / periodontal / periapical status of opposing teeth/implants
• 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
• The subjects as well as the implant site(s) fulfill the criteria for early loading (6 weeks until 3 months after implant placement)
• The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems
• The subject is available for the 5-year term of the investigation
• The subject is compliant with good oral hygiene

You may not qualify if:

• The subject is not able to give her/his informed consent of participating
• Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure
• 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
• Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area
• Alcohol or drug abuse as noted in subject records or in subject history
• Smoking of \>10 cigarettes/day
• Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
• Pathologic occlusion, e.g. severe bruxism or other destructive habits
• Lack of opposing dentition or unstable occlusion
• Ongoing infections, endodontic or periodontal problems in opposing teeth or implants
• Subject shows an unacceptable oral hygiene
• Subject has allergic or adverse reactions to the restorative material.
• Bone augmentation of more than 3mm vertical height performed less than 3 months prior to planned implant placement.
• Long-term bis-phosphonate therapy

Sponsors & Collaborators

• Nobel Biocare: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (7)

Guido Heydecke

Hamburg, 20246, Germany

Location

Nikolaus and Alexandra Behneke

Mainz, 55131, Germany

Location

Eugenio Romeo

Milan, 20143, Italy

Location

Edoardo Stellini

Padua, 35128, Italy

Location

Alessandro Pozzi

Rome, 00133, Italy

Location

Università degli Studi di Sassari

Sassari, Italy

Location

Marco Ferrari

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Mouth, Edentulous

Interventions

Denture, Overlay

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Guido Heydecke, Prof

  Poliklinik für Zahnärztliche Prothetik, University Hamburg

  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

• Edoardo Stellini, Prof

  University of Padova, Italy

  PRINCIPAL INVESTIGATOR

• Nikolaus and Alexandra Behneke, Prof., Dr.

  University of Mainz, Germany

  PRINCIPAL INVESTIGATOR

• Silvio Meloni, Dr.

  Università degli Studi di Sassari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: November 2, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 16, 2018

Record last verified: 2018-07

Locations

DE (2); IT (5)