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

NCT ID: NCT02127112

Last Updated: 2016-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Alveolar Process Defect

Keywords

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Ridge Augmentation Bone regeneration Guided Bone Regeneration Partially Edentulous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Block Allograft plus Matrix Allograft

The positive control treatment will include a block allograft plus a demineralized bone matrix moldable allograft.

Group Type ACTIVE_COMPARATOR

Block Allograft plus Matrix Allograft

Intervention Type PROCEDURE

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

Moldable Matrix Allograft

Intervention Type PROCEDURE

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

Moldable Matrix Allograft

In the test arm of the study the treatment will include a demineralized bone matrix moldable allograft.

Group Type EXPERIMENTAL

Moldable Matrix Allograft

Intervention Type PROCEDURE

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

Interventions

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Block Allograft plus Matrix Allograft

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

Intervention Type PROCEDURE

Moldable Matrix Allograft

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

Intervention Type PROCEDURE

Other Intervention Names

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Cancellous block allograft Optecure + CCC Optecure + CCC Resorbable bone pins

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Henry Greenwell

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henry Greenwell, DMD, MSD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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Graduate Periodontics Clinic, University of Louisville

Louisville, Kentucky, United States

Site Status

U of L Dental School

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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14.0265

Identifier Type: -

Identifier Source: org_study_id