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Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts

NCT02515058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-01-23

Study results available
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Summary

The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).

Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.

Conditions

  • Alveolar Bone Loss

Interventions

DEVICE

PUROS (Ridge Preservation bone grafting surgery)

Ridge preservation bone grafting after tooth extraction

DEVICE

FDBA (Ridge Preservation bone grafting surgery)

Ridge preservation bone grafting after tooth extraction

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Brian L. Mealey, DDS, MS · UT Health Science Center at San Antonio, School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515058 on ClinicalTrials.gov