Clinical Research Study to Evaluate the Stain Removal Efficacy

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Tooth Stain Removal

Treatments: Drug: Stannous Fluoride Toothpaste (SnF); Drug: Colgate Fluoride Toothpaste (CDC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06242769

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

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Group I

Active Comparator group

Description:

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

Treatment:

Drug: Stannous Fluoride Toothpaste (SnF)

Drug: Colgate Fluoride Toothpaste (CDC)

Group II

Placebo Comparator group

Description:

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

Treatment:

Drug: Stannous Fluoride Toothpaste (SnF)

Drug: Colgate Fluoride Toothpaste (CDC)