CompletedNot Applicable

Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials

United States44 participantsStarted 2016-07

Plain-language summary

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.

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

% Vital Bone Formation (Histological)

Timeframe: 18-20 weeks after ridge preservation

Trial details

NCT IDNCT02802319

SponsorThe University of Texas Health Science Center at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09

Results submitted2018-12-13

View on ClinicalTrials.gov More Alveolar Bone Loss trials