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Safety Study of Gintuit™ in Subjects Requiring Socket Grafting

NCT01929954 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-09-24

No results posted yet for this study

Summary

This is a prospective, randomized, controlled, parallel group Phase 1/2 assessment of the safety of GINTUIT versus Bio-Gide in subjects who have a posterior tooth requiring extraction. The incidence and severity of adverse events will be summarized by group (GINTUIT and Bio-Gide).

Conditions

  • Edentulous Alveolar Ridge

Interventions

BIOLOGICAL

Gintuit

One time placement of Gintuit over socket graft.

DEVICE

Bio-Gide

One time placement of Bio-Gide over socket graft.

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Kevin G. Murphy, DDS, MS · Kevin G. Murphy Associates, P.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01929954 on ClinicalTrials.gov