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ImplantNCT02175550

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

A study testing NR CC in people with Implant and Healthy, run by Nobel Biocare.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Implant, Healthy
What is being tested?
NR CC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
No sites listed yet
Study dates
Mar 2011to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

About this study

Official title: 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.

Read more

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.

Conditions
Implant, Healthy
Being tested
NR CC
Keywords
partially edentulous, maxilla, implants, Conical connection, Nobel Biocare, NobelReplace, Immediate loading, One- stage surgery, Two- stage surgery, supported restoration, patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NR CCDevice

Study groups in NCT02175550
Study groupRoleWhat they receive
NR CCExperimentalNot described
Receives: Device: NR CC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone levels and bone remodeling at the implant sites

    The parameter will be measured at 1, 2, 3 and 5 years after implant insertion

    Measured: yearly, from baseline up to 5 years

Secondary outcomes (5)

  1. Soft Tissue Index

    The parameter will be measured at 1, 2, 3 and 5 years after implant insertion

    Measured: yearly, from baseline up to 5 years

  2. Pink Aesthetic Score (PES)

    The parameter will be measured at 1, 2, 3 and 5 years after implant insertion

    Measured: yearly, from baseline up to 5 years

  3. Bleeding on Probing (BoP)

    The parameter will be measured at 1, 2, 3 and 5 years after implant insertion

    Measured: yearly, from baseline up to 5 years

  4. Patient satisfaction

    Patient satisfaction will be assessed at 1, 2, 3 and 5 years after implant insertion

    Measured: yearly, from baseline up to 5 years

  5. success and survival rates of implants.

    Success and survival rate will be assessed at 1, 2, 3 and 5 years after implant insertion

    Measured: yearly, from baseline up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2014 (estimated)
  2. Study startMar 2011
  3. Primary completionJul 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02175550
Sponsor's protocol ID
T-179
Status last verified
Mar 2021
First submitted
20 Jun 2014
Last updated
3 Mar 2021
Results posted
No
Data monitoring committee
No

Publications

  • Fugl A, Zechner W, Pozzi A, Heydecke G, Mirzakhanian C, Behneke N, Behneke A, Baer RA, Nolken 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.

    PubMed 27864641

Questions about this trial

What is this clinical trial studying?

A study testing NR CC in people with Implant and Healthy, run by Nobel Biocare.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone levels and bone remodeling at the implant sites (time frame: yearly, from baseline up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02175550, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021; AzTrials last refreshed its copy on 28 Oct 2026.

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