Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials

Completed · Not applicable

Conditions studied: Alveolar Bone Loss

In brief

The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bovine xenograft and porcine xenograft materials.This 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 porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subjects will have a non-molar tooth extracted and the socket grafted with either test or control graft material. At the time of dental implant placement 18-20 weeks after tooth extraction a small core biopsy specimen will be removed from the implant site. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.

Key facts

Study ID

NCT02802319

Run by

The University of Texas Health Science Center at San Antonio

People needed

44

Starts

2016-07-01

Expected to finish

2018-09-01

Last updated by the study team

2019-01-08

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UT Health Science Center School of Dentistry — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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