ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 212 for:    Louisville AND placement

Ridge Augmentation Comparing a Block Allograft to a Demineralized Bone Matrix Allograft.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02127112
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

Brief Summary:
This study with compare the ridge dimension changes for a block allograft vs. a demineralized bone matrix moldable allograft.

Condition or disease Intervention/treatment Phase
Alveolar Process Defect Procedure: Block Allograft plus Matrix Allograft Procedure: Moldable Matrix Allograft Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Active Comparator: Block Allograft plus Matrix Allograft
The positive control treatment will include a block allograft plus a demineralized bone matrix moldable allograft.
Procedure: Block Allograft plus Matrix Allograft
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

Procedure: Moldable Matrix Allograft
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

Experimental: Moldable Matrix Allograft
In the test arm of the study the treatment will include a demineralized bone matrix moldable allograft.
Procedure: Moldable Matrix Allograft
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




Primary Outcome Measures :
  1. Site width (horizontal) changes by comparing the pre- to post-augmentation dimensions of hard tissues. [ Time Frame: 4 months ]
    Measurement of the horizontal changes will be completed with a manual periodontal probe


Secondary Outcome Measures :
  1. Site height (vertical) changes by comparing the pre- to the post-augmentation dimensions of hard tissues. [ Time Frame: 4 months ]
    Measurement of of height will be used with an acrylic stent and a manual periodontal probe.

  2. Histologic composition of the healed ridge. [ 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
  • Healthy person that is at least 18 years old.
  • Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

  • Patients with debilitating systemic diseases, diseases that significantly affect the periodontium, or psychological problems that would interfere with treatment.
  • Previous head and neck radiation or chemotherapy within the previous 12 months.
  • Patients with known allergy to any of the materials that will be used in the study.
  • Smokers.
  • Patients who need prophylactic antibiotics prior to dental procedures.
  • Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV bisphosphonates.
  • Patients who are pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127112


Locations
United States, Kentucky
Graduate Periodontics Clinic, University of Louisville
Louisville, Kentucky, United States, 40202
U of L Dental School
Louisville, Kentucky, United States, 40205
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Henry Greenwell, DMD, MSD University of Louisville

Responsible Party: Henry Greenwell, Principle Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT02127112     History of Changes
Other Study ID Numbers: 14.0265
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by Henry Greenwell, University of Louisville:
Ridge Augmentation
Bone regeneration
Guided Bone Regeneration
Partially Edentulous