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A Clinical Trial to Evaluate Kerecis Oral™ Compared to Autogenous Free Gingival Graft (AFGG) Tissue to Augment Gingival Soft Tissue and Wound Healing

NCT03664401 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-09-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate Omega-3 Wound™ as an alternative to autogenous free gingival grafts harvested from the palate to treat human subjects with insufficient KT (\< 2 mm)

Conditions

  • Mucogingival Deformity - Insufficient Keratinized Tissue

Interventions

DEVICE

Kerecis Oral™

OTHER

Free Gingival Graft

A free gingival autograft from patient palate placed and secured on wound bed

Sponsors & Collaborators

  • Tufts University School of Dental Medicine

    collaborator OTHER

  • Kerecis Ltd.

    lead INDUSTRY

Principal Investigators

  • Nadeem Karimbux, DMD, MMSc · Tufts University of Dental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2017-09-01
Completion
2017-12-01
FDA Drug
Yes
FDA Device
Yes

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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 NCT03664401 on ClinicalTrials.gov