An Assessment of Bone Augmentation in Post-Extraction Sockets

NCT00641316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-07-19

Study results available
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Summary

When a tooth is extracted the ridge of bone that held the tooth in place begins to heal and over time new bone grows to fill the empty space left by the missing tooth. Sometimes this process works very well and new bone grows to completely fill the socket, at other times new bone fails to fill in the space completely and patients are left with uneven bone-fill.

Grafted extraction sockets may fill with bone faster and more evenly than those without grafts, allowing the dentist to have greater control over the healing process and to repair the area with dental implants in a shorter period of time.

This study will help determine if grafting an extraction socket, with or without enriching the graft material, is an added benefit when compared to allowing the socket to heal naturally.

The study will also assess how well two different dental implant designs used to restore the area will function over time.

Conditions

  • Unrestorable Dentition
  • Post-Extraction Sockets

Interventions

PROCEDURE

AtraumaticTeeth Extraction

Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites

PROCEDURE

Atraumatic Teeth Extraction/Grafted Extraction Sockets

Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites

PROCEDURE

Atraumatic Teeth Extraction/Grafted Extraction Sockets

Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Autologous Platelet-Rich Plasma (PRP) allowed to heal for 2 months followed by dental implant therapy to the sites

PROCEDURE

Atraumatic Teeth Extraction/Grafted Extraction Sockets

Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Platelet-Derived Growth Factors (PDGF) allowed to heal for 2 months followed by dental implant therapy to the sites

Sponsors & Collaborators

  • BioHorizons, Inc.

    collaborator INDUSTRY
  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Michael S Reddy, DMD, DMSc · University of Alabama at Birmingham

  • Nicolaas C Geurs, DDS, MS · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-04-30
Completion
2012-11-30

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 NCT00641316 on ClinicalTrials.gov