Expired Study
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San Antonio, Texas 78229


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

HSC2014-454H


NCT ID:

NCT02275767


Secondary ID:


Study Acronym:


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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The University of Texas Health Science Center at San Antonio


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

66


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Brian L Mealey, DDS, MS
Principal Investigator
UT Health Science Center at San Antonio, School of Dentistry

Study Dates

Start Date:October 2014
Completion Date:November 2016
Completion Type:Anticipated
Primary Completion Date:October 2016
Primary Completion Type:Anticipated
Verification Date:February 2016
Last Changed Date:February 8, 2016
First Received Date:October 22, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:% residual graft material (histological)
Time Frame:18-20 weeks after ridge preservation
Safety Issues:False
Description:histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery
Outcome Type:Primary Outcome
Measure:% vital bone formation (histological)
Time Frame:18-20 weeks after ridge preservation
Safety Issues:False
Description:histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery

Study Interventions

Intervention Type:Device
Name:50% cortical/50% cancellous FDBA
Description:Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA
Arm Name:Combination 50% cortical/50% cancellous FDBA
Intervention Type:Device
Name:100% cortical FDBA
Description:Ridge preservation after tooth extraction using 100% cortical FDBA
Arm Name:100% cortical FDBA
Intervention Type:Device
Name:100% cancellous FDBA
Description:Ridge preservation after tooth extraction using 100% cancellous FDBA
Arm Name:100% cancellous FDBA

Study Arms

Study Arm Type:Active Comparator
Arm Name:100% cancellous FDBA
Description:Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
Study Arm Type:Active Comparator
Arm Name:100% cortical FDBA
Description:Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
Study Arm Type:Experimental
Arm Name:Combination 50% cortical/50% cancellous FDBA
Description:Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The University of Texas Health Science Center at San Antonio

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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