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NCT03095976

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

Completed NA Results posted Last updated 14 April 2021
What this trial tests

NA trial testing Amnion-Chorion allograft membrane on the root surface of periodontally diseased site. in Periodontal Diseases in 4 participants. Completed in 10 September 2019.

Timeline
14 June 2017
Primary endpoint
10 September 2019
10 September 2019

Quick facts

Lead sponsorIndiana University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment4
Start date14 June 2017
Primary completion10 September 2019
Estimated completion10 September 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Indiana University

Who can join

Adults 18 to 75, any sex, with Periodontal Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Probing Depth Change Primary · Baseline and 6 months

Probing depth was measured at intrabony defect following surgical procedure.

GroupValue95% CI
Test Group4.22± 0.73
Clinical Attachment Change Primary · 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.

GroupValue95% CI
Test Group2.44± 2.24

Sponsor's own description

The purpose of this pilot project is to evaluate the efficacy of application of Amnion-Chorion allograft membrane on the root surface of periodontally diseased teeth in conjunction with bone substitute covered by Amnion-Chorion allograft in a combination Guided Tissue Regeneration (GTR) treatment of periodontal intrabony and furcation defects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Periodontal Diseases

Currently open trials in the same condition.

Other Indiana University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03095976.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing