Trial Outcomes & Findings for Amnion-Chorion Allograft Barrier Used for Root Surface and Guided Tissue Regeneration (NCT NCT03095976)

NCT ID: NCT03095976

Last Updated: 2021-04-14

Results Overview

Probing depth was measured at intrabony defect following surgical procedure.

Recruitment status

COMPLETED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2021-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Test Group Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects. Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.: Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Amnion-Chorion Allograft Barrier Used for Root Surface and Guided Tissue Regeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Group n=4 Participants Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects. Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.: Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	53.53 years STANDARD_DEVIATION 15.41 • n=5 Participants
Sex: Female, Male Female	1 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	2 Participants n=5 Participants
Race (NIH/OMB) White	2 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
Region of Enrollment United States	4 participants n=5 Participants
Iniital Probing Depth	7.67 millimeter STANDARD_DEVIATION 1.12 • n=5 Participants
Gingival Recession	0.44 millimeter STANDARD_DEVIATION 1.01 • n=5 Participants
Clinical Attachement Level	8.11 millimeter STANDARD_DEVIATION 1.62 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Probing depth was measured at intrabony defect following surgical procedure.

Outcome measures

Outcome measures
Measure	Test Group n=4 Participants Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects. Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.: Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects
Probing Depth Change	4.22 millimeter Standard Deviation 0.73

PRIMARY outcome

Timeframe: Baseline and 6 months

Clinical Attachment is defined as the sum of probing depth and gingival recession. The amount of gain of attachment level will be measured.

Outcome measures

Outcome measures
Measure	Test Group n=4 Participants Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects. Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.: Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects
Clinical Attachment Change	2.44 mm Standard Deviation 2.24

Adverse Events

Test Group

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. Yusuke Hamada

Indiana University School of Dentistry

Phone: 317-274-5121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place