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

University of Louisville20 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Alveolar Process Defect

Interventions

Block Allograft plus Matrix AllograftPROCEDURE

A cancellous block allograft plus a demineralized bone matrix allograft will be used as the positive control treatment.

Moldable Matrix AllograftPROCEDURE

The test arm of this study will include a demineralized bone matrix allograft placed over resorbable bone pins.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Graduate Periodontics Clinic, University of Louisville

Louisville, Kentucky, United States

U of L Dental School

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

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

Measurement of the horizontal changes will be completed with a manual periodontal probe

Time frame: 4 months

Secondary Outcomes

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

Measurement of of height will be used with an acrylic stent and a manual periodontal probe.

Time frame: 4 months

Histologic composition of the healed ridge.

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.

Time frame: 4 month

Data from ClinicalTrials.gov

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