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The Influence of Bone Allograft Particle Sizes on the Quantity and Quality of New Bone Formation in Grafted Extraction Sockets and Edentulous Ridges

NCT03468998 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-03-06

Study results available
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Summary

This study will evaluate the effect of allograft bone particle size on the bone quantity and quality following socket grafting and lateral ridge augmentation in preparation for endosseous implant placement.

Pre (baseline)- and post-grafting (3 months for sockets and 6 months for edentulous ridges) clinical as well as 2- and 3-dimensional radiographic measurements will be used to evaluate the differences between sites grafted with small vs. large particle sized bone allografts.

Histological analysis will be performed at time of surgical re-entry of grafted sites to place the dental implants, and assessed for differences in new bone formation between the 2 types of grafts.

Conditions

  • Alveolar Ridge Augmentation
  • Alveolar Ridge Preservation

Interventions

DEVICE

Socket Grafting with small particle allograft

Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket

DEVICE

Socket Grafting with large particle allograft

Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket

DEVICE

Lateral ridge augmentation with small particle allograft

Small Particle Bone Allograft of 0.25-1.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane

DEVICE

Lateral ridge augmentation with large particle allograft

Large Particle Bone Allograft of 1.0-2.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Ramzi V Abou-Arraj, DDS, MS · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2022-03-30
Completion
2022-12-15
FDA Device
Yes

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 NCT03468998 on ClinicalTrials.gov