Trial Outcomes & Findings for Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites (NCT NCT03215667)

Last Updated: 2021-01-25

Results Overview

Cone-beam computed tomography (CBCT) was taken at the ridge preservation procedure (baseline) and 3 months after the procedure. The horizontal ridge width was measured at 1, 3, 5 and 7 mm below the alveolar bone crest. Overall change is the average of all measurements.

Recruitment status

TERMINATED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

Change from Baseline at 3 months

Results posted on

2021-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Device Treatment easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Overall Study STARTED	9
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Device Treatment easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Overall Study Physician Decision	4

Baseline Characteristics

Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device Treatment n=9 Participants easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Age, Continuous	58.6 years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	7 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

PRIMARY outcome

Timeframe: Change from Baseline at 3 months

Outcome measures

Outcome measures
Measure	Device Treatment n=5 Participants easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Change in Radiographic Measurements of Bone Ridge Dimensions Overall	1.59 mm Standard Deviation 1.05
Change in Radiographic Measurements of Bone Ridge Dimensions 1 mm below the alveolar bone crest	1.89 mm Standard Deviation 1.03

SECONDARY outcome

Timeframe: Change from baseline at 5 months

Pre- and post-surgery casts were made from impressions and scanned with a digital scanner. The soft tissue width was measured at 1, 3 and 5 mm below the ridge crest. Overall change is the average of all measurements.

Outcome measures

Outcome measures
Measure	Device Treatment n=5 Participants easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Change in Digital Measurements of Soft Tissue Dimensions Overall	0.99 mm Standard Deviation 2.18
Change in Digital Measurements of Soft Tissue Dimensions 1mm below the ridge crest	2.57 mm Standard Deviation 1.35

Adverse Events

Device Treatment

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

Sunstar Americas, Inc.

Phone: 8477944276

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60