CompletedNot Applicable

Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts

United States44 participantsStarted 2015-09

Plain-language summary

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.

Who can participate

Age range18 Years – 89 Years

SexALL

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 rad…

What they're measuring

% Vital Bone Formation (Histological)

Timeframe: 3 months after ridge preservation

Trial details

NCT IDNCT02515058

SponsorThe University of Texas Health Science Center at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-09

Results submitted2017-09-27