Efficacy of Manual Toothbrushes in Removing Tooth Stains

Colgate-Palmolive

Status and phase: Enrolling; Phase 3

Conditions: Tooth Discoloration

Treatments: Drug: NaF; Drug: Na MFP

Study type: Interventional

Funder types: Industry

Identifiers

NCT06486974

CRO-2024-08-STN-DRW-DR-BGS

Details and patient eligibility

About

Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.

Full description

The aim of this study is to evaluate the effectiveness of manual toothbrushes in reducing tooth staining after 6 weeks of unsupervised, daily use by participants.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed Informed Consent Form;
• Male and female subjects, aged 18-70, inclusive;
• Good general health and good oral health based on the opinion of the study investigator;
• Presence of permanent natural anterior teeth (no veneers/crowns/restorations that may interfere with this study scoring procedures);
• A minimum composite mean of 1.5 ≥ determined by the Lobene Tooth Stain Index;
• Available for the duration of the study;
• Clinical evidence of a tendency to form extrinsic stains on anterior teeth.

Exclusion criteria

• Presence of orthodontic appliances/retainers involving scorable teeth;
• Presence of partial removable/fixed dentures and/or restorations involving scorable teeth;
• Tumor(s) of the soft or hard tissues of the oral cavity;
• Obvious signs of periodontal disease rampant caries, or any condition that the dental examiner considers exclusionary from the study;
• Five or more carious lesions requiring immediate care;
• Use of antibiotics, stain-inducing medications, and/or on any prescription that might interfere with the study outcome;
• Concurrent participation in another clinical study;
• Self-reported pregnancy and/or lactating women;
• Have used professional whitening product within one (1) year or had a dental prophylaxis (professional dental cleaning) within thirty (30) days - prior to the start of the study;
• History of allergies to oral care/personal care consumer products or their ingredients;
• History of alcohol and/or drug abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Group 1

Experimental group

Description:

Colgate MaxFresh Toothpaste - 0.243% NaF (1100 ppm F) Total Polish 23 CHS TB Colgate Active Prevention Manual Toothbrush

Treatment:

Drug: NaF

Group 2

Active Comparator group

Description:

Colgate Great Regular Flavor Toothpaste - 0.76% Na MFP (1000 ppm F) Colgate Adult Extra Clean soft-bristle toothbrush

Treatment:

Drug: Na MFP