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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.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
C16G2 Varnish, Placebo Varnish
John F. Pittaway, DMD
Not yet recruiting
C3 Jian, Inc.
Published on BioPortfolio: 2016-12-28T23:38:21-0500
An open-label and single-blind phase 2 study to evaluate the oral microbiology, safety and tolerability of multiple C16G2 Varnish and Strip applications in male and female dental subjects ...
The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish. Single-center, double-blind, controlled Phase 2 study with parallel groups of children. Subjects wil...
The purpose of this study is to determine whether semi-annual fluoride varnish applications combined with caregiver counseling are effective in preventing and reducing a severe form of den...
Clinical study to evaluate the efficiency of Flairesse fluoride varnish in improving dental health in South African school children.
The purpose of this study is to compare the efficacy of fluoride varnish applied once or twice a year with counseling to counseling alone in preventing early childhood caries (tooth decay ...
The aim of this study was to evaluate microbiological changes, oral soft tissue toxicity, and caries-preventive effect of an experimental titanium tetrafluoride (TiF) varnish compared with a commercia...
The aim of this study was to compare the effect of Nd:YAG laser to that of a new varnish: MI Varnish with RECALDENT (GC), for the treatment of dentin hypersensitivity, with a follow-up of 6 months. D...
To describe caregivers' understanding of fluoride varnish.
The aim was to evaluate the effect of fluoride varnish on the shear bond strength (SBS) on polished and non-polished intact and demineralized enamel. Bovine incisors (half demineralized) were used. Bi...
To investigate the remineralising effect and bacterial growth inhibition of 38% silver diamine fluoride (SDF) solution and 5% sodium fluoride (NaF) varnish on artificial dentine caries lesions.
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.
Dentistry is the study, management and treatment of diseases and conditions affecting the mouth, jaw, teeth and their supporting tissues (Oxford Medical Dictionary) The work of a dentist ranges from regular patient check-up to orthodontics and surgery....
Microbiology (from Greek μῑκρος, mīkros, "small"; βίος, bios, "life"; and -λογία, -logia) is the study of microscopic organisms, either unicellular (singl...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...