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Immediate Implant Placement in the Molar Regions

Primary Purpose

Periodontitis, Dental Caries, Periapical Periodontitis

Status

Completed

Phase

Early Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

Use of a membrane to cover bonedefects around implant

Use of bonechips to fill up defects around implant

Use of membrane and bonechips to manage defects

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Implant, Immediate placement, Molar tooth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

The Royal Dental College of Aarhus

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00226148

First Posted

September 23, 2005

Last Updated

September 8, 2009

Sponsor

University of Aarhus

Collaborators

The Danish Medical Research Council

1. Study Identification

Unique Protocol Identification Number

NCT00226148

Brief Title

Immediate Implant Placement in the Molar Regions

Official Title

Immediate Implant Placement in the Molar Regions

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Aarhus

Collaborators

The Danish Medical Research Council

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis, Dental Caries, Periapical Periodontitis

Keywords

Implant, Immediate placement, Molar tooth

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Use of a membrane to cover bonedefects around implant

Intervention Type

Device

Intervention Name(s)

Use of bonechips to fill up defects around implant

Intervention Type

Procedure

Intervention Name(s)

Use of membrane and bonechips to manage defects

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann Wenzel, Prof.Dr.Odont, Ph.d.,DDS

Organizational Affiliation

The Royal Dental College of Aarhus

Official's Role

Study Chair

Facility Information:

Facility Name

The Royal Dental College of Aarhus

City

Aarhus

ZIP/Postal Code

DK-8000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

22117841

Citation

Urban T, Kostopoulos L, Wenzel A. Immediate implant placement in molar regions: a 12-month prospective, randomized follow-up study. Clin Oral Implants Res. 2012 Dec;23(12):1389-97. doi: 10.1111/j.1600-0501.2011.02319.x. Epub 2011 Nov 25.

Results Reference

derived

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Immediate Implant Placement in the Molar Regions

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