N/A
N=43
Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
Alveolar Bone Loss
Bottom Line
View on ClinicalTrials.gov: NCT02515058 ↗Enrolled (actual)
43
Serious AEs
2.3%
Results posted
Nov 2017
Primary outcome: Primary: % Vital Bone Formation (Histological) — 27.19; 24.08 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PUROS (Ridge Preservation bone grafting surgery) (Device); FDBA (Ridge Preservation bone grafting surgery) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % Vital Bone Formation (Histological) |
27.19; 24.08 | — |
| SECONDARY % Residual Graft Material (Histological) |
23.38; 22.96 | — |
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.
Eligibility 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
- 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
Data sourced from ClinicalTrials.gov (NCT02515058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.