Clinical Research Study to Evaluate the Stain Removal Efficacy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06242769

Enrollment

Registered

2024-02-05

Start date

2020-07-27

Completion date

2020-09-14

Last updated

2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Stain Removal

Keywords

Composite Lobene, extrinsic stain

Brief summary

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.

Interventions

DRUGStannous Fluoride Toothpaste (SnF)

test

DRUGColgate Fluoride Toothpaste (CDC)

negative control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Puerto Rico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026