Histological Comparison of Ridge Preservation Using Mineralized FDBA Alone Versus a Combined Mineralized-Demineralized Freeze Dried Bone Allograft

October 1, 2014 updated by: Brian L Mealey, The University of Texas Health Science Center at San Antonio

Histological Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Mineralized Freeze Dried Bone Allograft Alone Versus a Combined Mineralized-Demineralized Freeze Dried Bone Allograft

This entire protocol involves procedures that are standard care. The purpose of the research is to evaluate whether there are any differences in new bone formation following tooth extraction and grafting of the extraction socket with either 100% mineralized FDBA (FDBA) or a combination of 70% mineralized & 30% demineralized FDBA (DFDBA). Both FDBA and DFDBA are commonly used in dentistry for this purpose. Until recently, there has been no human evidence of differences in new bone formation with one material versus another. Recently, DFDBA has been shown to provide a greater percentage of vital bone formation than FDBA. No studies have been done on materials that provide a combination of demineralized and mineralized FDBA for ridge preservation. That is the purpose of this study.

There will be two subject groups in this study. All subjects will require extraction of at least one non-molar tooth, followed by replacement of the missing teeth with dental implants. Each group will have 22 subjects. The primary distinction between groups will be the use of either a combination of 70% mineralized & 30% demineralized FDBA or 100% mineralized FDBA: Group 1 will have 70% mineralized & 30% demineralized FDBA grafted into the extraction socket for ridge preservation. Group 2 will have 100% mineralized FDBA grafted into the extraction socket for ridge preservation. The allocation of subjects into group 1 or 2 will based on numbers drawn from a stack of sealed envelopes. A small flap will be reflected to an extent about 3-4mm beyond the bony walls of the socket. A measuring stent will be placed and measurements of ridge width and ridge height will be taken and recorded to the nearest 0.5mm. Ridge width will be measured using a ridge caliper at a point approximately 4mm apical to the facial and lingual bony crest. Ridge height will also be measured. The tooth will be extracted and the subject will then be randomized by drawing a sealed envelope from the stack. Either 100% mineralized FDBA or a combination of 70% mineralized & 30% demineralized FDBA will be placed in the socket to restore the ridge to appropriate contour. A dense polytetrafluoroethylene (PTFE) membrane will then be placed over the socket orifice extending about 3mm beyond the bony socket walls. A PTFE suture will be placed over the membrane to secure it in place. Primary closure will not be attempted. The patient will be seen 7-10 days after extraction/ridge preservation to assess healing. The subject will be seen again 21-28 days to remove the PTFE membrane and to assess clinical healing.

At the time of implant placement, the measuring stent and caliper will be used to determine the ridge width and ridge height again. The implant site will be prepared using a hollow trephine which allows retention of the bony core. The bone removed from the osteotomy site remaining in the trephine will be prepared for histologic examination and analyzed for new bone growth. The following histologic parameters will be measured: percent vital bone formation; percent residual graft material; and, percent nonmineralized connective tissue/bone marrow. Following initial preparation of the implant site with the trephine, an implant of the appropriate length and diameter will be placed. A healing abutment will then be placed. All subjects will be examined at 7-10 days following implant placement. The study will end at the time of this follow up visit. The patient will then be referred to his/her restorative dentist for final restoration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio (Dental School)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • single rooted tooth requiring extraction
  • have adequate restorative space for a dental implant-retained restoration
  • have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal
  • have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket

Exclusion Criteria:

  • not meeting inclusion criteria
  • active localized or systemic infection other than periodontitis.
  • inadequate bone dimensions or restorative space dimensions to place a dental implant
  • presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, or autoimmune diseases.
  • positive medical history of endocarditis following oral or dental surgery.
  • sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants (per package insert)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mineralized FDBA alone
Socket grafting with mineralized freeze-dried bone allograft alone
Device: Mineralized freeze-dried bone allograft alone
Experimental: Combination of mineralized and deminieralized FDBA
Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone
Device: Combination of Mineralized and demineralized freeze-dried bone allograft alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent New Vital Bone Formation
Time Frame: 18-20 weeks
Bone core biopsy will be evaluated histologically for percent new vital bone formation
18-20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Residual Graft Material and Percent Connective Tissue
Time Frame: 18-20 weeks
Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue
18-20 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ridge Width and Ridge Height
Time Frame: At time of implant placement, which is 18-20 weeks after grafting of extraction socket
Ridge width and height are measured at time of tooth extraction & grafting, and again 18-20 weeks later at time of implant placement. Changes in ridge height and width are determined.
At time of implant placement, which is 18-20 weeks after grafting of extraction socket

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

August 14, 2013

First Posted (Estimate)

August 16, 2013

Study Record Updates

Last Update Posted (Estimate)

October 6, 2014

Last Update Submitted That Met QC Criteria

October 1, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC20120278H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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