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Completed

NCT Number: NCT02487784

Ridge Augmentation: Particulate v/s Block Graft

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Block allograft

Procedure

A cancellous block allograft plus corticocancellous particulate allograft will be used as the positive control treatment.

Other names: Cancellous block allograft

Particulate allograft + autogenous bone chips

Procedure

The test arm of this study will include a mix of particulate bone allograft and autogenous bone chips.

Other names: Particulate + ABC

Primary outcomes

  1. Horizontal ridge width changes

    Time frame: 4 months

    Site width (horizontal) changes by comparing the pre- to the 4 month post- augmentation dimensions of hard tissues.

Secondary outcomes

  1. Vertical ridge height changes

    Time frame: 4 months

    Site height (vertical) changes by comparing the pre- to the 4 month post-augmentation dimensions of hard tissues.

  2. Histologic composition of the graft

    Time frame: 4 months

    Histologic composition at 4 month post graft. (Histologic percent vital bone, nonvital bone and trabecular space.)

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 1, 2015
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

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