Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft

Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft: A Comparative Clinical, Histological, and Micro-computed Tomography Study

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Ridge Preservation
• Intervention / Treatment: Device: PRF; Device: FDBA; Procedure: Blood Clot

Detailed Description

This is a randomized controlled clinical study evaluating the efficacy of four treatment modalities for ridge preservation after extraction of a tooth in preparation for dental implant placement. After tooth extraction the alveolar crest remodels during healing with reductions in vertical and horizontal dimensions. The resulting reduced dimensions after healing of the alveolar crest may be inadequate to successfully place a dental implant to replace the missing tooth. In an attempt to minimize the reductions in dimensions and provide mature healthy bone to support the dental implant, different ridge preservation techniques (treatment of the extraction socket) have been utilized.

Forty subject from the UCSF Dental School who will be having a tooth extracted and replaced with a dental implant will be randomly assigned into the four ridge preservation treatment groups. After three months of healing bone samples from the ridge preservation site will be collected during the implant placement when bone is removed during the osteotomy preparation for the implant. Samples will be evaluated for the extent and quality of bone healing via histomorphometric and micro-CT analysis. Clinical measures of alveolar ridge dimensions will be taken before and after tooth extraction to determine extent of dimensional stability under the different treatment groups.

The four treatments modalities for ridge preservation include autologous platelet rich fibrin (PRF), PRF+freeze dried bone allograft (FDBA), FDBA, collagen barrier membrane. Subjects will be enrolled in the study from the time the socket treated to the time of implant placement (3 months). The results of this study will help to elucidate the extent and quality of bone healing using four different methods for ridge preservation in preparation for implant placement. Further, this study will advance our knowledge of PRF, an autologous sourced blood product used in dentoalveolar surgeries with proven in-vitro qualities but still requiring more extensive clinical testing to demonstrate its full clinical utility.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Single rooted teeth requiring extraction
2. Intact buccal and lingual plate within approximately 3-4 mm from gingival crest
3. No clinical or radiographic signs of periapical pathology
4. Acceptable oral hygiene

Exclusion Criteria:

1. Unable to comply with necessary scheduled visits
2. Poor oral hygiene
3. Failing/failed endodontic treatment with history/presence of sinus tracts
4. Pregnant woman or patients who intend to become pregnant
5. Tobacco use
6. Immunosuppressed
7. Type I or type II diabetes
8. Patient with any blood disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF	Device: PRF; Autologous blood product used to graft extraction socket
Experimental: PRF+FDBA	Device: PRF; Autologous blood product used to graft extraction socket; Device: FDBA; Graft material used to graft extraction socket
Active Comparator: FDBA	Device: FDBA; Graft material used to graft extraction socket
Active Comparator: Blood Clot	Procedure: Blood Clot; Surgical treatment of extraction socket without addition of graft material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Vital Bone	Percentage of vital bone at healed extraction socket	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Mineral Density	The bone mineral density (measured via micro-CT) at healed extraction sockets	3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Mark Ryder, DDS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2015
• Primary Completion (Actual): May 9, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 14-13360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes