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A 5-year Clinical Evaluation Study on NobelReplace Conical Connection Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02175550
Recruitment Status : Unknown
Verified March 2017 by Nobel Biocare.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare

Brief Summary:

A new Nobel Biocare implant, NobelReplace Conical Connection (NR CC) has been developed. The implant is a two piece design to allow both one- and two- stage surgical procedures. The entire implant surface has a porous titanium oxide of approximately 10µm thick (TiUnite) to promote and maintain primary stability, which later on leads to secondary stability.

NR CC implants are used as the foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to an entire arch of bridgework. The implants are also intended as retentive elements for overdenture applications.

The present study is designed to evaluate, after the insertion of the NR CC, the marginal bone levels and bone remodelling at the implant sites over various time points up to 5 years. Parameters as soft tissue index, pink aesthetic score (PES) and bleeding on probing (BoP) are as well evaluated together with implant success and survival rate.

Using the OHIP-14 questionnaire patients satisfaction is assessed. The results of this clinical investigation will demonstrate clinical safety and reliability of the NR CC using different treatment options.


Condition or disease Intervention/treatment Phase
Implant Healthy Device: NR CC Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Prospective, Single Cohort, Multi-centre Study Evaluating the NobelReplace Conical Connection Implants Supported Single -Unit Crowns in the Maxilla.
Study Start Date : March 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: NR CC Device: NR CC



Primary Outcome Measures :
  1. Bone levels and bone remodeling at the implant sites [ Time Frame: yearly, from baseline up to 5 years ]
    The parameter will be measured at 1, 2, 3 and 5 years after implant insertion


Secondary Outcome Measures :
  1. Soft Tissue Index [ Time Frame: yearly, from baseline up to 5 years ]
    The parameter will be measured at 1, 2, 3 and 5 years after implant insertion

  2. Pink Aesthetic Score (PES) [ Time Frame: yearly, from baseline up to 5 years ]
    The parameter will be measured at 1, 2, 3 and 5 years after implant insertion

  3. Bleeding on Probing (BoP) [ Time Frame: yearly, from baseline up to 5 years ]
    The parameter will be measured at 1, 2, 3 and 5 years after implant insertion

  4. Patient satisfaction [ Time Frame: yearly, from baseline up to 5 years ]
    Patient satisfaction will be assessed at 1, 2, 3 and 5 years after implant insertion

  5. success and survival rates of implants. [ Time Frame: yearly, from baseline up to 5 years ]
    Success and survival rate will be assessed at 1, 2, 3 and 5 years after implant insertion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obtained informed consent from the subject.
  • The subject shall be at least 18 years of age and have passed secession of growth
  • The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems. (The patient is committed to the study
  • The subject requires single unit implant restoration in the anterior maxilla (FDI 15-25); (ADA 4-13)
  • The tooth at the planned study site of interest is extracted or lost at least 2 months before the date of implantation
  • Healthy implantation site
  • Full mouth bleeding on probing (FMBoP) and full mouth plaque index (FMPI) are both lower or equal to 25%
  • The subject shall have a favorable and stable occlusal relationship
  • Natural roots are adjacent to the implant site
  • Maximum two single unit restorations per patient
  • The patient is suitable for a 1-stage surgical procedure
  • The patient is suitable for immediate temporization without full occlusal loading
  • Subject's acceptance of the scheduled program of clinical and radiographic analysis and maintenance.

Exclusion Criteria:

  • Insufficient bone volume at the implant site for placing a NobelReplace CC NP 3.5 implant with a length of at least 8 mm.
  • Major bone augmentation procedure at the site of implantation
  • Primary stability of the placed implant is ≤35Ncm
  • Implant insertion of ≥ 45Ncm
  • Acute, untreated periodontitis
  • Health conditions, which do not permit the surgical treatment
  • Any disorders in the planned implant area such as previous tumors, chronic one disease (such as rheumatoid disease)
  • Infections in adjacent tissue of the planned implantation site
  • Previous oro-maxillo-facial radiotherapy
  • Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc)
  • Alcohol or drug abuse as noted in subject records or in subject history
  • Heavy smoking (>10 cigarettes/day)
  • Uncontrolled diabetes
  • Severe bruxism or other destructive habits
  • Pregnant or lactating woman
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT02175550    
Other Study ID Numbers: T-179
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Keywords provided by Nobel Biocare:
partially edentulous
maxilla
implants
Conical connection
Nobel Biocare
NobelReplace
Immediate loading
One- stage surgery
Two- stage surgery
supported restoration
patients