Immediate Implant Placement in the Molar Regions

September 8, 2009 updated by: University of Aarhus

The purpose of this study is to look at the bonehealing when a molar has been extracted and immediately replaced by an implant leaving some defects around the implant.

The defects are being treated in three different with the hypothesis that the three ways of treatment result in equal bonehealing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized clinically controlled study with three group of each thirty patients, where the bonehealing after immediate implantplacement in molarregions is being investigated.

Totally 90 patients are going to get a molar tooth extracted and immediately replaced with an implant (Brånemark System, Wide Platform). The molar tooth should be in such a condition that is has to be extracted.

Extracting a molar leaves a defect which cannot completely be filled out by an implant. The 90 patients are therefore randomised into 3 groups according to how the perimarginal bonedefects around the placed implants are being treated: 1. Bonechips 2. Membrane 3. Bonechips+Membrane. The bonehealing of the defects around the implants are then compared the groups in between. The amount of newly formed bone is being estimated too by digital radiography and subtractionradiography. Furthermore the prognosis for immediate placed implants in molar regions in relation to the method of defectreconstruction one year after crown delivery is also being investigated. All the investigations are conducted with the Ho-hypothesis that there is no difference in the bonehealing the three groups in between.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Early Phase 1

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

  • Denmark
      • Aarhus, Denmark, DK-8000
        • The Royal Dental College of Aarhus

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A molar tooth which has to be extracted
  • Healthy persons with only mild systemic disease with no functional limitation

Exclusion Criteria:

  • Pregnant
  • Any disease that is influencing the turnover of bone or oral mucosa

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: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Digitial radiography of the implants at placement, 3 month, 6 month, at abutmentoperation, at crownplacement, 3 month after crownplacement and 6 month after crownplacement.
Time Frame: see above
see above

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

The Danish Medical Research Council

Investigators

  • Study Chair: Ann Wenzel, Prof.Dr.Odont, Ph.d.,DDS, The Royal Dental College of Aarhus

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

September 1, 2005

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 23, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (Estimate)

September 26, 2005

Study Record Updates

Last Update Posted (Estimate)

September 10, 2009

Last Update Submitted That Met QC Criteria

September 8, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005/0091
  • 22-04-0281

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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