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OpenTrials
Completed

NCT Number: NCT01529814

Assessment of Integration Success of an Implant System With a Novel Abutment Attachment Design in Early Loaded Cases

Integration success rates measured by resistance to countertorque testing will be higher for the experimental implant design than for the control implants.

Completed

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Key information

Conditions

Partial Edentulism Stomatognathic Diseases Tooth Disease Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Mayor

Santiago, Chile

About this study

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 countertorque testing and cumulative success rate in cases that are loaded early

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

Treatment and study plan

Implant with new abutment connection

Device

New abutment connection implant system

Other names: Osseotite Endosseous dental implant

Nanotite Certain tapered implant

Device

Nanotite Certain Tapered (standard abutment connection) implant

Other names: Nanotite endosseous dental implant

Primary outcomes

  1. Primary stability countertorque measures

    Time frame: 2 months

    Resistance to countertorque measures showing primary stability success of implants

Secondary outcomes

  1. Cumulative success rate

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

ZimVie

Industry

Registry information

Official study title

A Prospective Randomized-controlled Study of the Integration Success Rate of an Implant System With a Novel Abutment Attachment in Cases Loaded Early

Acronym: Comet

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2012
Registry last updated
Mar 28, 2022

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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