NCT03043885

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 5, 2018

Completed
Last Updated

December 5, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

February 1, 2017

Results QC Date

October 17, 2018

Last Update Submit

November 14, 2018

Conditions

Alveolar Ridge Preservation

Outcome Measures

Primary Outcomes (1)

  • Percentage of Vital Bone

    Percentage of vital bone at healed extraction socket

    3 months

Secondary Outcomes (1)

  • Bone Mineral Density

    3 months

Study Arms (4)

PRF

EXPERIMENTAL
Device: PRF

PRF+FDBA

EXPERIMENTAL
Device: FDBADevice: PRF

FDBA

ACTIVE COMPARATOR
Device: FDBA

Blood Clot

ACTIVE COMPARATOR
Procedure: Blood Clot

Interventions

FDBADEVICE

Graft material used to graft extraction socket

FDBAPRF+FDBA
PRFDEVICE

Autologous blood product used to graft extraction socket

PRFPRF+FDBA
Blood ClotPROCEDURE

Surgical treatment of extraction socket without addition of graft material

Blood Clot

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Blood Coagulation

Intervention Hierarchy (Ancestors)

HemostasisBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Results Point of Contact

Title
Daniel Clark
Organization
UCSF
daniel.clark@ucsf.edu
415.476.1101

Study Officials

  • Mark Ryder, DDS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2017

First Posted

February 6, 2017

Study Start

January 5, 2015

Primary Completion

May 9, 2016

Study Completion

March 1, 2017

Last Updated

December 5, 2018

Results First Posted

December 5, 2018

Record last verified: 2018-11