Immediate Implant Placement in the Molar Regions

This study has been completed.
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00226148
First received: September 23, 2005
Last updated: September 8, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Periodontitis
Dental Caries
Periapical Periodontitis
Procedure: Use of a membrane to cover bonedefects around implant
Device: Use of bonechips to fill up defects around implant
Procedure: Use of membrane and bonechips to manage defects
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immediate Implant Placement in the Molar Regions

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: September 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226148

Locations
Denmark
The Royal Dental College of Aarhus
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
The Danish Medical Research Council
Investigators
Study Chair: Ann Wenzel, Prof.Dr.Odont, Ph.d.,DDS The Royal Dental College of Aarhus
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Urban, Dental School, Aarhus University
ClinicalTrials.gov Identifier: NCT00226148     History of Changes
Other Study ID Numbers: 2005/0091, 22-04-0281
Study First Received: September 23, 2005
Last Updated: September 8, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Implant
Immediate placement
Molar tooth

Additional relevant MeSH terms:
Dental Caries
Periapical Periodontitis
Periodontitis
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases
Periodontal Diseases
Mouth Diseases

ClinicalTrials.gov processed this record on July 20, 2014