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CompletedNCT00226148Updated Sep 10, 2009

Immediate Implant Placement in the Molar Regions

An Early Phase 1 interventional study of Use of a membrane to cover bonedefects around implant and Use of bonechips to fill up defects around implant in Periodontitis, Dental Caries and Periapical Periodontitis, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-10.

Sponsored by University of Aarhus · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Periodontitis
  • Dental Caries
  • Periapical Periodontitis

Keywords

  • Implant
  • Immediate placement
  • Molar tooth
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 92 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant
  • Any disease that is influencing the turnover of bone or oral mucosa
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
92 participants (actual)

Interventions

  • ProcedureUse of a membrane to cover bonedefects around implant
  • DeviceUse of bonechips to fill up defects around implant
  • ProcedureUse of membrane and bonechips to manage defects
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • The Royal Dental College of Aarhus
    Aarhus, DK-8000, Denmark
08

References and documents

Publications

  • 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. PubMed 22117841 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00226148
Lead sponsor
University of Aarhus
Collaborators
The Danish Medical Research Council
First posted
Sep 26, 2005
Start date
Sep 2005
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Sep 10, 2009

Study contacts

Ann Wenzel, Prof.Dr.Odont, Ph.d.,DDS
study chair · The Royal Dental College of Aarhus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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