Ridge Augmentation: Particulate v/s Block Graft

Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Versus Corticocancellous Particulate Allograft Mixed With Autogenous Bone Chips

The primary aims of this study are to compare the clinical and histologic results of bone regeneration with a cancellous block allograft versus MinerOss Cortico cancellous particulate allograft mixed with autogenous bone chips after 4 months of healing. Titanium reinforced hd-PTFE (Cytoplast) membrane GBR will be used to cover the bone grafts.

Specific Aim 1: To compare the baseline to 4 month change in clinical ridge width and height.

Specific Aim 2: To compare the histologic percent of vital and nonvital bone and trabecular space at 4 months.

The primary outcome variable is the change in horizontal ridge width. The secondary outcomes are the change in ridge height and the percent histologic composition of the augmented site.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: Particulate allograft + autogenous bone chips; Procedure: Block allograft

Detailed Description

30 patients will be treated using the principles of guided bone regeneration and ridge augmentation. 15 test patients will receive a corticocancellous particulate allograft mixed with autogenous bone chips. The positive control group of 15 patients will receive a cancellous block allograft. Both the groups will receive a hd-PTFE (Cytoplast) barrier membrane. An allograft can be defined as bone that can be obtained from a different individual of the same species (human donor bone) whereas a autograft can be defined as bone that can be obtained from the same individual. Following flap reflection, vertical measurements will be done using a acrylic occlusal stent and horizontal measurements will be done using a specially designed caliper. Approximately 4 months post surgery, a trephine core will be taken from the grafted site immediately prior to the implant placement and submitted for histologic processing. The last step in the study will be to obtain a trephine core (2.7 X 6mm). After the core is harvested a dental implant will be placed. Implant placement should be considered a post study treatment procedure. There is no intent to investigate implant placement outcome. Step serial sections will be taken from each longitudinally sectioned core. The sections will be stained with hematoxylin and eosin. Ten slides per patient will be prepared with at least 4 sections per slide. For each patient 6 of 10 slides will be assessed. The mean percentages of vital and non vital bone and trabecular space will be determined for each patient by using an American Optical Microscope at 150X with a 10 X10 ocular grid. Histologic preparation will result in destruction of the trephine cores. Means and standard deviations will be calculated for all parameters. A paired t-test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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 on oral bisphosphonates > 3 years or any IV bisphosphonates.
• Patients who are pregnant.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Particulate allograft + autogenous bone.; In the test arm of the study the treatment will include a mix of MinerOss CorticoCancellous Particulate allograft + autogenous bone chips.	Procedure: Particulate allograft + autogenous bone chips; The test arm of this study will include a mix of particulate bone allograft and autogenous bone chips.; Other Names: Particulate + ABC
Active Comparator: Block allograft; The positive control treatment will include a block allograft plus Mineross corticocancellous particulate allograft.	Procedure: Block allograft; A cancellous block allograft plus corticocancellous particulate allograft will be used as the positive control treatment.; Other Names: Cancellous block allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal ridge width changes	Site width (horizontal) changes by comparing the pre- to the 4 month post- augmentation dimensions of hard tissues.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical ridge height changes	Site height (vertical) changes by comparing the pre- to the 4 month post-augmentation dimensions of hard tissues.	4 months
Histologic composition of the graft	Histologic composition at 4 month post graft. (Histologic percent vital bone, nonvital bone and trabecular space.)	4 months

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Henry Greenwell, DMD, MSD, Director of Graduate Periodontics, School of Dentistry, University of Louisville.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 31, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: 15.0530