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A Study to Evaluate the Safety and Microbiology of C16G2 Varnish Administered in Multiple Doses to Dental Subjects

2016-12-28 23:38:21 | BioPortfolio

Summary

The purpose of this single-blind study is to evaluate whether C16G2 Varnish administered in multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries.

Description

A single-blind, randomized, placebo-controlled Phase 2 study to evaluate the safety and oral microbiology of C16G2 Varnish application in male and female dental subjects 12-75 years of age. This multi-center study will evaluate multiple study drug administrations of C16G2 Varnish or Placebo.

The study will enroll subjects into up to three study arms. Up to 33 subjects will receive multiple doses of study drug applied with a small brush typically used in dental varnish administration. Subjects will be enrolled in an 8:3 ratio. The Sponsor will perform unblinded microbiology review on an ongoing basis to determine whether to enroll additional 11 subjects into the next dose cohort or to terminate enrollment based on microbiology data.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Dental Caries

Intervention

C16G2 Varnish, Placebo Varnish

Location

John F. Pittaway, DMD
Kalispell
Montana
United States
59901

Status

Not yet recruiting

Source

C3 Jian, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-28T23:38:21-0500

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Medical and Biotech [MESH] Definitions

An inner coating, as of varnish or other protective substance, to cover the dental cavity wall. It is usually a resinous film-forming agent dissolved in a volatile solvent, or a suspension of calcium hydroxide in a solution of a synthetic resin. The lining seals the dentinal tubules and protects the pulp before a restoration is inserted. (Jablonski, Illustrated Dictionary of Dentistry, 1982)

The predisposition to tooth decay (DENTAL CARIES).

A liquid resinous varnish solubilized in a volatile solvent which may be combined with a pigment. It forms a hard, glossy, and protective coating when applied to wood or metal.

Diagnostic tests conducted in order to measure the increment of active DENTAL CARIES over a period of time.

Dental caries involving the tooth root, cementum, or cervical area of the tooth.

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