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Completed

NCT Number: NCT02175550

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

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.

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Key information

Conditions

Implant Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NR CC

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nobel Biocare

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2014
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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