Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.

March 14, 2016 updated by: Dentsply Sirona Implants and Consumables

An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.

The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • Dept. of Implant Dentistry, New York University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7450
        • Dept. of Prosthodontics, School of Dentistry, University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of written informed consent
  • Age 18 - 75 years
  • Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
  • Edentulous in the area/s if implant placement for more than 2 months

Exclusion Criteria:

  • Untreated caries and/or periodontal disease of residual dentition
  • Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
  • Absence of occlusal stability in centric occlusion
  • Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
  • Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
  • Pregnancy
  • Present alcohol or drug abuse
  • Tobacco smoking during the last 6 months
  • Unable or unwilling to return for follow-up visits for a period of 3 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ASTRA TECH Implant System; Fixture ST
Ø 4.5 cm in lengths 9-13 mm
Device: ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
EXPERIMENTAL: Biomet 3i; Osseotite® Implants
Ø 4.0 cm in lengths 8.5-13 mm
Device: 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Bone Level Changes
Time Frame: 3 years after implant placement (baseline)
Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.
3 years after implant placement (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dentsply Sirona Implants and Consumables

Investigators

  • Principal Investigator: Dennis P Tarnow, D.D.S. Prof., Dept. of Implant Dentistry, New York University (to March 2011)
  • Principal Investigator: Stuart Froum, Dr, Dept. of Implant Dentistry, New York University (from March 2011)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (ESTIMATE)

September 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 13, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YA-MIC-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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