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Clinical Evaluation of the Efficacy of a Marketed Dentifrice on Plaque and Gingivitis

NCT03214406 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2021-05-11

Study results available
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Summary

Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study involving approximately 160 subjects to complete. Subjects were randomly assigned to either the test product (Arm \& Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline mean whole-mouth plaque and gingival scores and age.Subjects brushed with their assigned dentifrice two times (2X) daily and were evaluated for gingivitis, bleeding and plaque at Baseline and after 4-, 8-, and 12-weeks of product use. Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks.

Conditions

  • Plaque
  • Gingivitis

Interventions

DRUG

Arm & Hammer Advance White Brilliant Sparkle (Test product)

20% sodium bicarbonate

DRUG

Crest Cavity Protection Regular Toothpaste (Negative Control)

Negative control

Sponsors & Collaborators

  • Church & Dwight Company, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-08
Primary Completion
2010-08-03
Completion
2010-08-03

Countries

  • Canada

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 NCT03214406 on ClinicalTrials.gov