Trial Outcomes & Findings for Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft (NCT NCT03043885)

NCT ID: NCT03043885

Last Updated: 2018-12-05

Results Overview

Percentage of vital bone at healed extraction socket

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2018-12-05

Participant Flow

Participant milestones

Measure	Platelet-rich Fibrin PRF: Autologous blood product used to graft extraction socket	PRF+FDBA FDBA: Graft material used to graft extraction socket PRF: Autologous blood product used to graft extraction socket	FDBA FDBA: Graft material used to graft extraction socket	Blood Clot Blood Clot: Surgical treatment of extraction socket without addition of graft material
Overall Study STARTED	10	10	10	10
Overall Study COMPLETED	10	10	10	10
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Platelet-rich Fibrin n=10 Participants PRF: Autologous blood product used to graft extraction socket	PRF+FDBA n=10 Participants FDBA: Graft material used to graft extraction socket PRF: Autologous blood product used to graft extraction socket	FDBA n=10 Participants FDBA: Graft material used to graft extraction socket	Blood Clot n=10 Participants Blood Clot: Surgical treatment of extraction socket without addition of graft material	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=10 Participants	6 Participants n=10 Participants	8 Participants n=10 Participants	8 Participants n=10 Participants	29 Participants n=40 Participants
Age, Categorical >=65 years	3 Participants n=10 Participants	4 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=10 Participants	11 Participants n=40 Participants
Sex: Female, Male Female	6 Participants n=10 Participants	6 Participants n=10 Participants	5 Participants n=10 Participants	5 Participants n=10 Participants	22 Participants n=40 Participants
Sex: Female, Male Male	4 Participants n=10 Participants	4 Participants n=10 Participants	5 Participants n=10 Participants	5 Participants n=10 Participants	18 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 Participants n=10 Participants	10 Participants n=10 Participants	10 Participants n=10 Participants	10 Participants n=10 Participants	40 Participants n=40 Participants

PRIMARY outcome

Timeframe: 3 months

Percentage of vital bone at healed extraction socket

Outcome measures

Measure	Platelet-rich Fibrin n=10 Participants PRF: Autologous blood product used to graft extraction socket	PRF+FDBA n=10 Participants FDBA: Graft material used to graft extraction socket PRF: Autologous blood product used to graft extraction socket	FDBA n=10 Participants FDBA: Graft material used to graft extraction socket	Blood Clot n=10 Participants Blood Clot: Surgical treatment of extraction socket without addition of graft material
Percentage of Vital Bone	46 percentage of vital bone Standard Deviation 18	39 percentage of vital bone Standard Deviation 10	29 percentage of vital bone Standard Deviation 14	40 percentage of vital bone Standard Deviation 15

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Platelet-rich Fibrin n=10 Participants PRF: Autologous blood product used to graft extraction socket	PRF+FDBA n=10 Participants FDBA: Graft material used to graft extraction socket PRF: Autologous blood product used to graft extraction socket	FDBA n=10 Participants FDBA: Graft material used to graft extraction socket	Blood Clot n=10 Participants Blood Clot: Surgical treatment of extraction socket without addition of graft material
Bone Mineral Density	493 mg/cm3 Standard Deviation 70	521 mg/cm3 Standard Deviation 58	487 mg/cm3 Standard Deviation 64	551 mg/cm3 Standard Deviation 58

Adverse Events

Platelet-rich Fibrin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PRF+FDBA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FDBA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blood Clot

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Clark

UCSF

Phone: 415.476.1101

Email: daniel.clark@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place