Immediate Implant Placement in the Molar Regions

Periodontitis Clinical Trial

Official title:

Immediate Implant Placement in the Molar Regions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226148
• Other study ID #: 2005/0091
• Secondary ID: 22-04-0281
• Status: Completed
• Phase: Phase 0
• First received: September 23, 2005
• Last updated: September 8, 2009
• Start date: September 2005
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries
• Periapical Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Denmark	The Royal Dental College of Aarhus	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digitial radiography of the implants at placement, 3 month, 6 month, at abutmentoperation, at crownplacement, 3 month after crownplacement and 6 month after crownplacement.		see above	No