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

March 2, 2021 updated by: Nobel Biocare

An Open, Prospective, Single Cohort, Multi-centre Study Evaluating the NobelReplace Conical Connection Implants Supported Single -Unit Crowns in the Maxilla.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NR CC
Device: NR CC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
yearly, from baseline up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
yearly, from baseline up to 5 years
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
yearly, from baseline up to 5 years
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
yearly, from baseline up to 5 years
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
yearly, from baseline up to 5 years
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
yearly, from baseline up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nobel Biocare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • T-179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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