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CompletedNCT01529866BridgeUpdated Mar 28, 2022

Study of the Integration Success of an Implant System With a Novel Abutment Attachment Design in Immediate Loading Cases

An interventional study of New Abutment Connection implant and Nanotite Certain Tapered implant in Partial Edentulism and Tooth Disease, sponsored by ZimVie. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-28.

Sponsored by ZimVie · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Integration success rates measured by lack of implant mobility and crestal bone regression measurement will be higher for the experimental implant design than for the control implants.

Read the detailed description

In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by cumulative success rate in cases that are loaded immediately

02

Conditions studied

  • Partial Edentulism
  • Tooth Disease

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Keywords

  • clinical study
  • edentulism
  • dental implants
  • Nanotite Certain Tapered implant
  • randomized
  • crestal bone level
  • immediate loading
03

In context

Tooth Diseases

116 studies on the registry are indexed under Tooth Diseases; 14 are open to participants now.

This study's enrollment of 60 is above the median of 46 across 82 interventional studies indexed under Tooth Diseases.

Browse Tooth Diseases studies →

Lead sponsor

ZimVie is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients of either sex and older than 18 years of age
  • patients needing at least one dental implant to treat partial edentulism
  • patients physically able to tolerate surgical and restorative dental procedures
  • patients agreeing to all protocol visits

Exclusion criteria

Exclusion Criteria:

  • patients with infection or severe inflammation at the intended treatment sites
  • patients smoking greater than 10 cigarettes per day
  • patients with uncontrolled diabetes mellitus
  • patients with uncontrolled metabolic diseases
  • patients who received radiation treatment to the head in the past 12 months
  • patients needing bone grafting at the intended treatment sites
  • patients known to be pregnant at screening visit
  • patients with para-functional habits like bruxing and clenching
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    New abutment connection implant

    Implant with new abutment connection

    Device: New Abutment Connection implant

  • Active comparator
    Nanotite Certain Tapered implant

    Nanotite Certain Tapered (standard abutment connection) implant

    Device: Nanotite Certain Tapered implant

Interventions

  • DeviceNew Abutment Connection implant

    New abutment connection implant

    Also known as: Osseotite Endosseous dental implant

  • DeviceNanotite Certain Tapered implant

    Nanotite certain tapered (standard abutment connection) implant

    Also known as: Nanotite Endosseous dental implant

06

What researchers measure

Primary outcomes

  1. Cumulative success rate

    crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

    Time frame: 2 years

07

Study locations

1 site
  • Universidad de Chile
    Santiago, Chile
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01529866
Lead sponsor
ZimVie
Responsible party
Sponsor
First posted
Feb 9, 2012
Start date
Aug 2011
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Mar 28, 2022

Study contacts

Juan C Carvajal, DDS
principal investigator · University of Chile

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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