Efficacy of Manual Toothbrushes in Removing Tooth Stains

NCT ID: NCT06486974

Last Updated: 2024-09-25

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

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2024-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tooth Discoloration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Colgate MaxFresh Toothpaste - 0.243% NaF (1100 ppm F)

Total Polish 23 CHS TB Colgate Active Prevention Manual Toothbrush

Group Type EXPERIMENTAL

NaF

Intervention Type DRUG

Group 1 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study

Group 2

Colgate Great Regular Flavor Toothpaste - 0.76% Na MFP (1000 ppm F)

Colgate Adult Extra Clean soft-bristle toothbrush

Group Type ACTIVE_COMPARATOR

Na MFP

Intervention Type DRUG

Group 2 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study

Interventions

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NaF

Group 1 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study

Intervention Type DRUG

Na MFP

Group 2 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 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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Franklin Garcia-Godoy, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Global Research Consultants

Locations

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Spa Dental

Santo Domingo, , Dominican Republic

Site Status RECRUITING

Countries

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Dominican Republic

Central Contacts

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Franklin Garcia-Godoy, DDS, MS, PhD

Role: CONTACT

+1 (901) 488-1820

Facility Contacts

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Franklin Garcia-Godoy, DDS

Role: primary

809-562-1710

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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