Clinical Research Study to Evaluate the Stain Removal Efficacy

January 28, 2024 updated by: Colgate Palmolive

Clinical Research Study to Evaluate the Stain Removal Efficacy of a Toothpaste Containing Stannous Fluoride as Compared to Negative Control Toothpaste.

The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Dental Research Associates, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Signed Informed Consent Form
  • Good general health
  • Male and female subjects, aged 21-70, inclusive
  • Present 12 scoreable natural anterior teeth
  • A minimum mean Composite Lobene Index score of 1 or greater
  • Available for the duration of the study
  • Clinical evidence of a tendency to form extrinsic stain on anterior teeth

Exclusion Criteria:

  • Presence of orthodontic bands
  • Presence of partial removable dentures
  • Tumor(s) of the soft or hard tissues of the oral cavity
  • Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
  • Five or more carious lesions requiring immediate restorative treatment
  • Use of antibiotics or stain inducing medications any time during the one month prior to entry into the study
  • Participation in any other clinical study or test panel within the one month prior to entry into the study
  • Self-reported pregnancy and/or women who are breast feeding
  • Dental prophylaxis received in the past four weeks prior to baseline examinations
  • History of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide
  • On any prescription medicines that might interfere with the study outcome
  • History of alcohol and/or drug abuse
  • Exposed to a tooth whitening procedure during the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
Stannous Fluoride Toothpaste (SnF) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min
Drug: Stannous Fluoride Toothpaste (SnF)
test
Drug: Colgate Fluoride Toothpaste (CDC)
negative control
Placebo Comparator: Group II
Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min
Drug: Stannous Fluoride Toothpaste (SnF)
test
Drug: Colgate Fluoride Toothpaste (CDC)
negative control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Lobene Stain Index
Time Frame: measurement at baseline, 3 week & 6 week
subjects will be evaluated for tooth stain by the dental examiner
measurement at baseline, 3 week & 6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Augusto R Elias-Boneta, DMD, MSD, Dental Research Associates, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2020

Primary Completion (Actual)

September 14, 2020

Study Completion (Actual)

September 14, 2020

Study Registration Dates

First Submitted

January 28, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2020-04-STN-SNF-PR-BGS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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