Clinical Research Study to Evaluate the Stain Removal Efficacy

Phase 3

Completed

• Conditions: Tooth Stain Removal
• Interventions: Drug: Stannous Fluoride Toothpaste (SnF); Drug: Colgate Fluoride Toothpaste (CDC)

• Registration Number: NCT06242769
• Lead Sponsor: Colgate Palmolive

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-27
• Primary Completion: 2020-09-14
• Study Completion: 2020-09-14
• Status Verified: 2024-01
• Study First Submitted: 2024-01-28
• Study First Submitted QC: 2024-01-28
• Last Update Submitted: 2024-01-28
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Stannous Fluoride Toothpaste (SnF)	Stannous Fluoride Toothpaste (SnF) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min
Group II	Stannous Fluoride Toothpaste (SnF)	Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min
Group II	Colgate Fluoride Toothpaste (CDC)	Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min
Group I	Colgate Fluoride Toothpaste (CDC)	Stannous Fluoride Toothpaste (SnF) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min

Primary Outcome Measures

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

Trial Locations

Locations (1)

Dental Research Associates, Inc.; 🇵🇷 San Juan, Puerto Rico