Trial Outcomes & Findings for Ridge Preservation Comparing an Intrasocket Graft Alone to an Intrasocket Graft Plus a Facial Overlay Graft (NCT NCT01431131)

Results Overview

WIll be measured with a digital caliper at baseline and 4 months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Baseline and 4 months

Results posted on

2017-01-31

Participant Flow

The study was conducted between September 2011 and July 2012 in the Graduate Periodontics clinic at the University of Louisville School of Dentistry.

Participant milestones

Participant milestones
Measure	Intrasocket Graft Positive control, an intrasocket cancellous allograft is placed	Intrasocket Plus Facial Overlay Graft Intrasocket cancellous allograft plus a facial overlay bovine xenograft
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ridge Preservation Comparing an Intrasocket Graft Alone to an Intrasocket Graft Plus a Facial Overlay Graft

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intrasocket Graft n=12 Participants Positive control, an intrasocket cancellous allograft was placed	Intrasocket Plus Facial Overlay Graft n=12 Participants Intrasocket cancellous allograft plus a facial overlay bovine xenograft	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants	10 Participants n=107 Participants	20 Participants n=206 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Age, Continuous	52 years STANDARD_DEVIATION 16 • n=99 Participants	58 years STANDARD_DEVIATION 11 • n=107 Participants	55 years STANDARD_DEVIATION 14 • n=206 Participants
Gender Female	8 Participants n=99 Participants	5 Participants n=107 Participants	13 Participants n=206 Participants
Gender Male	4 Participants n=99 Participants	7 Participants n=107 Participants	11 Participants n=206 Participants
Region of Enrollment United States	12 participants n=99 Participants	12 participants n=107 Participants	24 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline and 4 months

WIll be measured with a digital caliper at baseline and 4 months.

Outcome measures

Outcome measures
Measure	Intrasocket Graft n=12 Participants Positive control, an intrasocket cancellous allograft was placed	Intrasocket Plus Facial Overlay Graft n=11 Participants Intrasocket cancellous allograft plus a facial overlay bovine xenograft
Horizontal Ridge Dimension	-1.6 mm Standard Deviation 0.8	-0.3 mm Standard Deviation 0.9

SECONDARY outcome

Timeframe: 4 months

Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages

Outcome measures

Outcome measures
Measure	Intrasocket Graft n=12 Participants Positive control, an intrasocket cancellous allograft was placed	Intrasocket Plus Facial Overlay Graft n=11 Participants Intrasocket cancellous allograft plus a facial overlay bovine xenograft
Histologic Healing of the Osseous Graft	35 percentage vital bone Standard Deviation 16	40 percentage vital bone Standard Deviation 16

Adverse Events

Intrasocket Graft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intrasocket Plus Facial Overlay Graft

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

Dr. Henry Greenwell, Principal Investigator

University of Louisville

Phone: 502-852-6928

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place