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

Information source: Biomet, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Partial Edentulism; Tooth Disease

Intervention: New Abutment Connection implant (Device); Nanotite Certain Tapered implant (Device)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Biomet, Inc.

Official(s) and/or principal investigator(s):
Juan C Carvajal, DDS, Principal Investigator, Affiliation: University of Chile

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Cumulative success rate

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Universidad de Chile, Santiago, Chile
Additional Information

Starting date: August 2011
Last updated: May 14, 2015

Page last updated: August 23, 2015

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