- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02515058
Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
Ridge Preservation Following Tooth Extraction Using Mineralized Freeze-Dried Bone Allograft Compared to PUROS Mineralized Bone Allograft
The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.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 cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called 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 resorbable collagen membrane. Following 3 months 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 Overview
Status
Conditions
Detailed Description
The study is designed to examine histologic wound healing following ridge preservation using cancellous bone allograft that has been prepared either by freeze-drying (FDBA) or by a solvent-based processing method (PUROS). 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 cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called 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 resorbable collagen membrane. Following 3 months 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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San Antonio, Texas, United States, 78229
- UT Health Science Center at San Antonio, School of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
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 |
---|---|
Experimental: PUROS (Non-Freeze-Dried bone allograft)
Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)
|
Ridge preservation bone grafting after tooth extraction
|
Active Comparator: FDBA (Freeze-Dried bone allograft)
Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)
|
Ridge preservation bone grafting after tooth extraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% Vital Bone Formation (Histological)
Time Frame: 3 months after ridge preservation
|
histologic determination of % of vital bone formation
|
3 months after ridge preservation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% Residual Graft Material (Histological)
Time Frame: 3 months after ridge preservation
|
histologic determination of % of residual bone graft material
|
3 months after ridge preservation
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brian L. Mealey, DDS, MS, UT Health Science Center at San Antonio, School of Dentistry
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-0552H
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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