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

December 6, 2016 updated by: Henry Greenwell, University of Louisville

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Graduate Periodontics Clinic, University of Louisville
      • Louisville, Kentucky, United States, 40205
        • U of L Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months
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.
4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Investigators

  • Principal Investigator: Henry Greenwell, DMD, MSD, University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14.0265

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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