Block Allograft plus Matrix Allograft
ProcedureA cancellous block allograft plus a demineralized bone matrix allograft will be used as the positive control treatment.
Other names: Cancellous block allograft, Optecure + CCC
NCT Number: NCT02127112
This study with compare the ridge dimension changes for a block allograft vs. a demineralized bone matrix moldable allograft.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Graduate Periodontics Clinic, University of Louisville, Louisville, Kentucky, United States
The patients' treatment will be randomly assigned by coin toss done by the mentor immediately after flap reflection. The examiner will be blinded to the treatment and will not have access to information indicating treatment assignment. The examiner will never see the patient between the time of grafting and complete healing at 4 months. The surgical procedure will consist of the reflection of a split-thickness flap to expose the alveolar ridge. Following complete exposure of the surgical site, vertical measurements will be taken with the acrylic occlusal stent in place, and horizontal measurements with a specially designed digital caliper. After initial surgical measurements, numerous cortical perforations will be performed with a round bur in the area of the augmentation. The control group will receive a block graft and bone screw for stabilization, with voids being filled by the Optecure+CCC®. The test group therapy will include graft with the Optecure+CCC® and the use of Bone Pin® for space maintenance. Horizontal dimension will be established by graft dimensions, bone screws, or bone pins when necessary, for each planned implant area. Longer span edentulous spaces will be divided into individual sites as follows: 5 mm from natural teeth to future mid-implant sites and 7 mm between two future mid-implant sites. The bone pins and bone blocks with bone screws will be placed to allow enough exposure for augmentation to achieve 9 mm horizontal width available for implant placement. Vertical and horizontal measurements will again be taken with the acrylic occlusal stent and calipers prior to flap closure. An resorbable membrane will cover both test and control groups. A monofilament suture material will be used. The surgical procedures will be documented with clinical photographs.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A cancellous block allograft plus a demineralized bone matrix allograft will be used as the positive control treatment.
Other names: Cancellous block allograft, Optecure + CCC
The test arm of this study will include a demineralized bone matrix allograft placed over resorbable bone pins.
Other names: Optecure + CCC, Resorbable bone pins
Time frame: 4 months
Measurement of the horizontal changes will be completed with a manual periodontal probe
Time frame: 4 months
Measurement of of height will be used with an acrylic stent and a manual periodontal probe.
Time frame: 4 month
At the time of re-entry, a trephine core specimen will be taken. This specimen will be examined under a microscope to determine the vital bone characteristics.
University of Louisville
Other
Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus Optecure Containing Cortico-Cancellous Chips Versus Optecure Containing Cortico-Cancellous Chips Alone.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.