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Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft

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ClinicalTrials.gov Identifier: NCT02275767
Recruitment Status : Completed
First Posted : October 27, 2014
Results First Posted : May 11, 2016
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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Brief Summary:

The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. 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 combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous 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 non-resorbable membrane. Following 18-20 weeks 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.


Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Device: 50% cortical/50% cancellous FDBA Device: 100% cortical FDBA Device: 100% cancellous FDBA Not Applicable

Detailed Description:

The study is designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The study is a 3-arm, parallel-design, randomized, prospective clinical trial. The test group subjects will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous 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 non-resorbable membrane. Following 18-20 weeks 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Combination 50% cortical/50% cancellous FDBA
Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
 Device: 50% cortical/50% cancellous FDBA
Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA
Active Comparator: 100% cortical FDBA
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
 Device: 100% cortical FDBA
Ridge preservation after tooth extraction using 100% cortical FDBA
Active Comparator: 100% cancellous FDBA
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
 Device: 100% cancellous FDBA
Ridge preservation after tooth extraction using 100% cancellous FDBA


Outcome Measures
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Primary Outcome Measures :
  1. % Vital Bone Formation (Histological) [ Time Frame: 18-20 weeks after ridge preservation ]
    histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery


Secondary Outcome Measures :
  1. % Residual Graft Material (Histological) [ Time Frame: 18-20 weeks after ridge preservation ]
    histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Patients will be included in this study if they qualify the following inclusion criteria:

  • Live within 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
  • Are able to attend a minimum of 6 visits over a 4-5 month period, as required by the study protocol
  • A single rooted tooth that has been identified as requiring extraction
  • Desire a dental implant to replace the missing tooth
  • 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.
  • Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential.
  • Are nonsmokers or former smokers. Current smokers may only be included if they smoke <10 cigarettes per day

Exclusion Criteria:

  • Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
  • Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule.
  • Patients will are mentally incompetent, prisoners, or pregnant.
  • Pregnant women or women intending to become pregnant during the study period.
  • Smokers who smoke >10 cigarettes per day
  • Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.
  • Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275767


Locations
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United States, Texas
UT Health Science Center at San Antonio, School of Dentistry
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Brian L Mealey, DDS, MS UT Health Science Center at San Antonio, School of Dentistry
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02275767    
Other Study ID Numbers: HSC2014-454H
First Posted: October 27, 2014    Key Record Dates
Results First Posted: May 11, 2016
Last Update Posted: May 11, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
 Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases