Trial Outcomes & Findings for Case Series of New Alloplastic Bone Graft Material (NCT NCT02221557)

Last Updated: 2017-08-10

Results Overview

Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration).

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

Change from baseline to 6 months

Results posted on

2017-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	New Alloplastic Bone Graft Material easy-graft (beta-Tricalcium Phosphate)
Overall Study STARTED	8
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Case Series of New Alloplastic Bone Graft Material

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	New Alloplastic Bone Graft Material n=8 Participants easy-graft (beta-Tricalcium Phosphate)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Widest ridge width	9.3 mm STANDARD_DEVIATION 2.5 • n=5 Participants
Deepest vertical depth	10.0 mm STANDARD_DEVIATION 2.3 • n=5 Participants
Widest open	8.3 mm STANDARD_DEVIATION 2.5 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 6 months

Outcome measures

Outcome measures
Measure	New Alloplastic Bone Graft Material n=5 Participants easy-graft (beta-Tricalcium Phosphate)
Percentage Change in Radiographic Measurement of Alveolar Ridge Height	1.2 percentage of change Standard Deviation 6.2

Adverse Events

New Alloplastic Bone Graft Material

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

Akane Takemura, R&D Senior Manager

Sunstar Americas, Inc.

Phone: 847-794-4276

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 30 days from the time submitted to the sponsor for review. Sponsor reserves the right to require the PI to remove sponsor's confidential information. Upon sponsor's written request, publication will be delayed up to 60 days to enable sponsor to secure adequate intellectual property protection.
Publication restrictions are in place

Restriction type: OTHER