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

Primary Purpose

Alveolar Bone Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
50% cortical/50% cancellous FDBA
100% cortical FDBA
100% cancellous FDBA
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UT Health Science Center at San Antonio, School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Combination 50% cortical/50% cancellous FDBA

100% cortical FDBA

100% cancellous FDBA

Arm Description

Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)

Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)

Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)

Outcomes

Primary Outcome Measures

% Vital Bone Formation (Histological)
histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery

Secondary Outcome Measures

% Residual Graft Material (Histological)
histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery

Full Information

First Posted
October 22, 2014
Last Updated
April 6, 2016
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT02275767
Brief Title
Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft
Official Title
Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination 50% cortical/50% cancellous FDBA
Arm Type
Experimental
Arm Description
Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
Arm Title
100% cortical FDBA
Arm Type
Active Comparator
Arm Description
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
Arm Title
100% cancellous FDBA
Arm Type
Active Comparator
Arm Description
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
Intervention Type
Device
Intervention Name(s)
50% cortical/50% cancellous FDBA
Intervention Description
Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA
Intervention Type
Device
Intervention Name(s)
100% cortical FDBA
Intervention Description
Ridge preservation after tooth extraction using 100% cortical FDBA
Intervention Type
Device
Intervention Name(s)
100% cancellous FDBA
Intervention Description
Ridge preservation after tooth extraction using 100% cancellous FDBA
Primary Outcome Measure Information:
Title
% Vital Bone Formation (Histological)
Description
histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery
Time Frame
18-20 weeks after ridge preservation
Secondary Outcome Measure Information:
Title
% Residual Graft Material (Histological)
Description
histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery
Time Frame
18-20 weeks after ridge preservation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian L Mealey, DDS, MS
Organizational Affiliation
UT Health Science Center at San Antonio, School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Health Science Center at San Antonio, School of Dentistry
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28452622
Citation
Demetter RS, Calahan BG, Mealey BL. Histologic Evaluation of Wound Healing After Ridge Preservation With Cortical, Cancellous, and Combined Cortico-Cancellous Freeze-Dried Bone Allograft: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Sep;88(9):860-868. doi: 10.1902/jop.2017.170155. Epub 2017 Apr 28.
Results Reference
derived

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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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