Clinical trial NCT00226148: Immediate Implant Placement in the Molar Regions
Official title: Immediate Implant Placement in the Molar Regions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Periodontitis
Dental Caries
Periapical Periodontitis
Keywords: Implant
Immediate placement
Molar tooth
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
First posted: 2005-09-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Digitial radiography of the implants at placement, 3 month, 6 month, at abutmentoperation, at crownplacement, 3 month after crownplacement and 6 month after crownplacement.
timeFrame: see above
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: The Royal Dental College of Aarhus
Study officials:
affiliation: The Royal Dental College of Aarhus
name: Ann Wenzel, Prof.Dr.Odont, Ph.d.,DDS
role: STUDY_CHAIR
References:
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.