Trial Outcomes & Findings for Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis (NCT NCT03213210)

Results Overview

Distance of probe penetration from gingival margin to bottom of peri-implant pocket

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Change from baseline at 12 months after the surgery

Results posted on

2021-04-08

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 the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant.
Overall Study STARTED	5
Overall Study 6-month Follow-up	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

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 the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant.
Overall Study Lost to Follow-up	2
Overall Study Study termination	3

Baseline Characteristics

Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis

Baseline characteristics by cohort

Baseline characteristics by cohort
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 the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant.
Age, Continuous	66.6 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 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	0 Participants n=5 Participants
Race (NIH/OMB) White	5 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 12 months after the surgery

Population: No subjects were examined at 12 months after the surgery.

Distance of probe penetration from gingival margin to bottom of peri-implant pocket

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At 12 months after the surgery

Population: No subjects were examined at 12 months after the surgery.

To be assessed by examiner and subject using the Visual Analog Scales

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline at 6 and 12 months after the surgery

Population: Marginal bone level was examined in 3 subjects at 6-month follow-up. No subjects were examined at 12 months after the surgery.

Change of marginal bone level on periapical standardized radiographs from baseline.

Outcome measures

Outcome measures
Measure	Device Treatment n=3 Participants easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant.
Change of Marginal Bone Level 6 months	3.3 percentage of bone height change Standard Deviation 5.8

SECONDARY outcome

Timeframe: Change from baseline at 6 and 12 months after the surgery

Population: No subjects were examined at 6 and 12 months after the surgery.

Distance between free gingival margin and mucogingival junction

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to at 6 and 12 months after the surgery

Population: No subjects were examined at 6 and 12 months after the surgery.

Distance of probe penetration from fixed reference to bottom of peri-implant

Outcome measures

Outcome data not reported

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