Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

February 25, 2014

Primary Completion Date

August 25, 2015

Study Completion Date

March 31, 2016

Conditions
PlaqueGingivitis
Interventions
DRUG

2 mg KSL-W

DRUG

4 mg KSL-W

DRUG

6 mg KSL-W

DRUG

10 mg KSL-W

DRUG

20 mg KSL-W

DRUG

30 mg KSL-W

DRUG

50 mg KSL-W

DRUG

75 mg KSL-W

DRUG

100 mg KSL-W

OTHER

Placebo

Cetylpyridinium chloride (CPC) as an additive, isomalt as a bulk sweetener, peppermint powder for flavoring, sucralose as an intense sweetener, colloidal silicon dioxide is a flow enhancer, magnesium stearate as a process aid, and the proprietary gum base formulation.

Trial Locations (1)

46202

Indiana University School of Dentistry, Oral Health Research Institute, Indianapolis

All Listed Sponsors
lead

U.S. Army Medical Research and Development Command

FED

NCT01877421 - Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population | Biotech Hunter | Biotech Hunter