Trial Outcomes & Findings for Clinical and Radiographic Evaluation of Demineralized Freeze-Dried Bone Allograft Versus Platelet Rich Fibrin for the Treatment of Periodontal Intrabony Defects in Humans (NCT NCT02154906)

Results Overview

measurement of CAL at the time of surgical intervention will be compared with measurement of CAL and bone level 6 months after surgery

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

baseline and 6 months after surgery

Results posted on

2016-07-01

Participant Flow

44 subjects were enrolled but 3 withdrew prior to group assignment, leaving N=41 assigned to groups

Participant milestones

Participant milestones
Measure	DFDBA DFDBA used to graft intrabony defect DFDBA	Autologous Platelet Rich Fibrin autologous platelet rich fibrin used to graft intrabony defect autologous platelet rich fibrin
Overall Study STARTED	21	20
Overall Study COMPLETED	19	17
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical and Radiographic Evaluation of Demineralized Freeze-Dried Bone Allograft Versus Platelet Rich Fibrin for the Treatment of Periodontal Intrabony Defects in Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DFDBA n=19 Participants DFDBA used to graft intrabony defect DFDBA	Autologous Platelet Rich Fibrin n=17 Participants autologous platelet rich fibrin used to graft intrabony defect autologous platelet rich fibrin	Total n=36 Participants Total of all reporting groups
Age, Continuous	52.3 years n=5 Participants	57.2 years n=7 Participants	55.0 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	17 participants n=7 Participants	36 participants n=5 Participants
Clinical Attachment Level	6.7 mm n=5 Participants	6.3 mm n=7 Participants	6.5 mm n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months after surgery

measurement of CAL at the time of surgical intervention will be compared with measurement of CAL and bone level 6 months after surgery

Outcome measures

Outcome measures
Measure	DFDBA n=19 Participants DFDBA used to graft intrabony defect DFDBA	Autologous Platelet Rich Fibrin n=17 Participants autologous platelet rich fibrin used to graft intrabony defect autologous platelet rich fibrin
Change in Clinical Attachment Level (CAL)	1.21 mm Standard Deviation 1.50	1.03 mm Standard Deviation 0.86

SECONDARY outcome

Timeframe: baseline and 6 months after surgery

measurement of radiographic bone level at the time of surgical intervention will be compared with measurement of bone level 6 months after surgery

Outcome measures

Outcome measures
Measure	DFDBA n=19 Participants DFDBA used to graft intrabony defect DFDBA	Autologous Platelet Rich Fibrin n=17 Participants autologous platelet rich fibrin used to graft intrabony defect autologous platelet rich fibrin
Change in Radiographic Bone Level	1.14 mm Standard Deviation 0.88	1.10 mm Standard Deviation 1.01

Adverse Events

DFDBA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Autologous Platelet Rich Fibrin

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

Brian L. Mealey

UT Health Science Center San Antonio

Phone: 210-567-3567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place