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Phase 2 Study to Evaluate the Microbiology and Safety of C16G2 Administered to Adult and Adolescent Dental Subjects

NCT02594254 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2019-08-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate if C16G2 Gel administered over a certain period of time either with a toothbrush or a custom dental tray can effectively kill bacteria in the mouth that cause dental cavities.

Conditions

  • Dental Caries

Interventions

DRUG

C16G2 Gel

Antimicrobial peptide

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Vantage Data Designs, Inc.

    collaborator INDUSTRY

  • SynteractHCR

    collaborator INDUSTRY

  • Agility Clinical, Inc.

    collaborator INDUSTRY

  • Armata Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Wolff, DDS, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-06-30
Completion
2016-09-30

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 NCT02594254 on ClinicalTrials.gov