Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges

June 26, 2014 updated by: Dentsply Sirona Implants and Consumables

An Open, Prospective, Controlled Study in the Maxilla to Evaluate Clinical Outcome of ASTRA TECH Implant System, OsseoSpeed™ Implants in Single Tooth Replacement Using an Immediate Loading Protocol in Extraction Sockets and Healed Ridges.

The purpose of this study is to evaluate survival for ASTRA TECH Implant System, OsseoSpeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. Patients in need of single standing implants replacing teeth in the maxilla within zone 15-25 will be included and followed for 5 years. Primary objective is implant survival rate at 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

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

  • Belgium
      • Ghent, Belgium, B-9000
        • Dental School Department Periodontology
  • Germany
      • Kiel, Germany, 241 05
        • Department of Oromaxillofacial Surgery, Hospital of the Christian- Albrechts University at Kiel
  • Spain
      • Barcelona, Spain, 08190
        • Universitat Internacional de Catalunya, Department de Odontología
  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7450
        • School of dentistry

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of written informed consent
  • 18 years of age and over
  • A minimum of 20 stable intra occlusal contacts after planned restoration
  • In need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25

Exclusion Criteria:

  • Untreated rampant caries and uncontrolled periodontal disease
  • Use of smoking tobacco at time of inclusion
  • History of pre-surgical bone augmentation, within 4 months, in the planned implant area
  • History of extraction without augmentation, within 3 months in the planned implant area
  • Absence of opposing dentition
  • Absence of adjacent (mesial and/or distal) natural tooth
  • Uncontrolled diabetes
  • Known pregnancy at time of inclusion
  • Present alcohol or drug abuse
  • Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
  • Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
  • Unable or unwilling to return for follow-up visits for a period of 5 years
  • Unrealistic esthetical demands
  • Unlikely to be able to comply with study procedures according to Investigators judgment
  • Already included in this study

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extraction Sockets
Immediate loading in extraction sockets.
Device: ASTRA TECH Implant System, OsseoSpeed™
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
Experimental: Healed Ridges
Immediate loading in healed ridges.
Device: ASTRA TECH Implant System, OsseoSpeed™
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
Experimental: Grafted Sites
Immediate loading of implants placed in grafted sites (four months healing after grafting).
Device: ASTRA TECH Implant System, OsseoSpeed™
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survival
Time Frame: 12 months after implant placement
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
12 months after implant placement

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: Lyndon Cooper, Prof, DDS, PhD, School of Dentistry, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 7, 2008

First Posted (Estimate)

July 8, 2008

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

June 26, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YA-OSS-0006

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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