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Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

NCT03219840 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-02-08

Study results available
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Summary

This placebo-controlled, double-blinded, randomized crossover study evaluates the plaque and gingivitis reducing capacity of Cetylpyridium Chloride (CPC) chewing gum, with mechanical oral hygiene. The study will enroll 73 students, faculty, and staff from the UTHealth School of Dentistry. Half of the eligible participants will be randomly assigned to get the CPC gum in the first treatment period (21 days), a wash-out period of 21 days, and then a placebo gum in the second treatment period (21 days). The other half will be assigned to follow the same schedule but with the treatment reversed. A statistician will perform the randomization. Primary outcomes are assessed by validated tools, such as the Plaque Index (PI), Gingival Index (GI), and percent of bleeding sites on probe (BOP).

Conditions

  • Gingivitis
  • Plaque, Dental
  • Periodontal Diseases

Interventions

DRUG

Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum

All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.

DRUG

Xylitol only chewing gum

All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.

Sponsors & Collaborators

  • CONFADENT Oral Technology, Kiss Industries LLC

    collaborator UNKNOWN

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Flavia Lakschevitz, DDS, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-18
Primary Completion
2018-09-08
Completion
2018-09-08
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 NCT03219840 on ClinicalTrials.gov