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Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population

NCT01877421 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2020-02-13

Study results available
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Summary

This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation.

Conditions

  • Plaque
  • Gingivitis

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.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Domenick T Zero, DDS, MS · Oral Health Research Institute, Indiana University School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-25
Primary Completion
2015-08-25
Completion
2016-03-31
FDA Drug
Yes

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 NCT01877421 on ClinicalTrials.gov