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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 : Completed
First Posted : June 26, 2014
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare

Tracking Information
First Submitted Date  ICMJE June 20, 2014
First Posted Date  ICMJE June 26, 2014
Last Update Posted Date March 3, 2021
Study Start Date  ICMJE March 2011
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 5-year Clinical Evaluation Study on NobelReplace Conical Connection Implants
Official Title  ICMJE An Open, Prospective, Single Cohort, Multi-centre Study Evaluating the NobelReplace Conical Connection Implants Supported Single -Unit Crowns in the Maxilla.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Implant
  • Healthy
Intervention  ICMJE Device: NR CC
Study Arms  ICMJE Experimental: NR CC
Intervention: Device: NR CC
Publications * Fügl A, Zechner W, Pozzi A, Heydecke G, Mirzakhanian C, Behneke N, Behneke A, Baer RA, Nölken R, Gottesman E, Colic S. An open prospective single cohort multicenter study evaluating the novel, tapered, conical connection implants supporting single crowns in the anterior and premolar maxilla: interim 1-year results. Clin Oral Investig. 2017 Jul;21(6):2133-2142. doi: 10.1007/s00784-016-2003-0. Epub 2016 Nov 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2014)
99
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Austria,   Germany,   Italy,   Serbia,   United States
 
Administrative Information
NCT Number  ICMJE NCT02175550
Other Study ID Numbers  ICMJE T-179
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nobel Biocare
Study Sponsor  ICMJE Nobel Biocare
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nobel Biocare
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP