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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03043885
Enrollment
40
Registered
2017-02-06
Start date
2015-01-05
Completion date
2017-03-01
Last updated
2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Ridge Preservation

Brief 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.

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.

Interventions

DEVICEFDBA

Graft material used to graft extraction socket

DEVICEPRF

Autologous blood product used to graft extraction socket

PROCEDUREBlood Clot

Surgical treatment of extraction socket without addition of graft material

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Vital Bone3 monthsPercentage of vital bone at healed extraction socket

Secondary

MeasureTime frameDescription
Bone Mineral Density3 monthsThe bone mineral density (measured via micro-CT) at healed extraction sockets

Participant flow

Participants by arm

ArmCount
Platelet-rich Fibrin
PRF: Autologous blood product used to graft extraction socket
10
PRF+FDBA
FDBA: Graft material used to graft extraction socket PRF: Autologous blood product used to graft extraction socket
10
FDBA
FDBA: Graft material used to graft extraction socket
10
Blood Clot
Blood Clot: Surgical treatment of extraction socket without addition of graft material
10
Total40

Baseline characteristics

CharacteristicTotalPRF+FDBAFDBABlood ClotPlatelet-rich Fibrin
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
11 Participants4 Participants2 Participants2 Participants3 Participants
Age, Categorical
Between 18 and 65 years
29 Participants6 Participants8 Participants8 Participants7 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
40 Participants10 Participants10 Participants10 Participants10 Participants
Sex: Female, Male
Female
22 Participants6 Participants5 Participants5 Participants6 Participants
Sex: Female, Male
Male
18 Participants4 Participants5 Participants5 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 100 / 100 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 100 / 10

Outcome results

Primary

Percentage of Vital Bone

Percentage of vital bone at healed extraction socket

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Platelet-rich FibrinPercentage of Vital Bone46 percentage of vital boneStandard Deviation 18
PRF+FDBAPercentage of Vital Bone39 percentage of vital boneStandard Deviation 10
FDBAPercentage of Vital Bone29 percentage of vital boneStandard Deviation 14
Blood ClotPercentage of Vital Bone40 percentage of vital boneStandard Deviation 15
Secondary

Bone Mineral Density

The bone mineral density (measured via micro-CT) at healed extraction sockets

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Platelet-rich FibrinBone Mineral Density493 mg/cm3Standard Deviation 70
PRF+FDBABone Mineral Density521 mg/cm3Standard Deviation 58
FDBABone Mineral Density487 mg/cm3Standard Deviation 64
Blood ClotBone Mineral Density551 mg/cm3Standard Deviation 58

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026