N/A
N=40
Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft
Alveolar Ridge Preservation
Bottom Line
View on ClinicalTrials.gov: NCT03043885 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Percentage of Vital Bone — 46; 39; 29; 40 percentage of vital bone
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FDBA (Device); PRF (Device); Blood Clot (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Vital Bone |
46; 39; 29; 40 | — |
| SECONDARY Bone Mineral Density |
493; 521; 487; 551 | — |
Summary
Improved predictability and quality of bone healing after a tooth is removed is clinically relevant, in that, it improves our ability to achieve successful implant placement at edentulous sites. Currently, a variety of grafting materials and biologic agents are utilized clinically to improve bone healing and provide sufficient dimensions of bone to support a dental implant. Platelet rich fibrin (PRF) is one such product that can be used for this application. PRF is a concentrated blood product attained from the patient's own blood consisting of a natural bioscaffold with integrated growth factors capable of sustained release. Once processed, PRF is implanted back into the patient at the wound or defect site to encourage healing. The literature regarding PRF is currently dominated by heterogeneous applications of PRF for reparative and regenerative therapies without a consensus of its clinical efficacy and appropriate application. In this clinical study, PRF will be evaluated to ascertain its clinical efficacy in improving bone formation and alveolar dimensional stability after tooth extraction. A classic bone grafting material used for this purpose, freeze dried bone allograft (FDBA), will be incorporated with the PRF or compared directly to PRF alone. It is hypothesized that the natural scaffold and incorporated growth factors of PRF augmented with the solubility resistance of FDBA will function as an ideal bioscaffold to promote bone healing to a greater extent compared to PRF, FDBA, or blood clot alone.
Eligibility Criteria
Inclusion Criteria
- Single rooted teeth requiring extraction
- Intact buccal and lingual plate within approximately 3-4 mm from gingival crest
- No clinical or radiographic signs of periapical pathology
- Acceptable oral hygiene
Exclusion Criteria
- Unable to comply with necessary scheduled visits
- Poor oral hygiene
- Failing/failed endodontic treatment with history/presence of sinus tracts
- Pregnant woman or patients who intend to become pregnant
- Tobacco use
- Immunosuppressed
- Type I or type II diabetes
- Patient with any blood disorder
Data sourced from ClinicalTrials.gov (NCT03043885). 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.