Clinical Research Study to Evaluate the Stain Removal Efficacy

NCT ID: NCT06242769

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-27

Study Completion Date

2020-09-14

Brief Summary

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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.

Detailed Description

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Conditions

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Tooth Stain Removal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group I

Stannous Fluoride Toothpaste (SnF) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min

Group Type ACTIVE_COMPARATOR

Stannous Fluoride Toothpaste (SnF)

Intervention Type DRUG

test

Colgate Fluoride Toothpaste (CDC)

Intervention Type DRUG

negative control

Group II

Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min

Group Type PLACEBO_COMPARATOR

Stannous Fluoride Toothpaste (SnF)

Intervention Type DRUG

test

Colgate Fluoride Toothpaste (CDC)

Intervention Type DRUG

negative control

Interventions

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Stannous Fluoride Toothpaste (SnF)

test

Intervention Type DRUG

Colgate Fluoride Toothpaste (CDC)

negative control

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Augusto R Elias-Boneta, DMD, MSD

Role: PRINCIPAL_INVESTIGATOR

Dental Research Associates, Inc

Locations

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Dental Research Associates, Inc.

San Juan, , Puerto Rico

Site Status

Countries

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Puerto Rico

Other Identifiers

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CRO-2020-04-STN-SNF-PR-BGS

Identifier Type: -

Identifier Source: org_study_id

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