Clinical Study to Assess the Efficacy of Professional Tooth Whitening Maintenance System

NCT ID: NCT06613347

Last Updated: 2025-05-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-07

Study Completion Date

2024-12-20

Brief Summary

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Clinical study to assess the efficacy of professional tooth whitening maintenance system of a Colgate toothpaste containing 5% Hydrogen Peroxide with a stain-fighter mouthwash as compared to only the stainfighter mouthwash and a negative control toothpaste

Detailed Description

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Conditions

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Staining

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Whitening Regimen

Group Type EXPERIMENTAL

whitening maintenance

Intervention Type OTHER

whitening maintenance regimen

Whitening MW

Group Type ACTIVE_COMPARATOR

whitening maintenance MW

Intervention Type OTHER

maintenance MW

Negative Control

Group Type PLACEBO_COMPARATOR

negative control

Intervention Type OTHER

negative control

Interventions

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whitening maintenance

whitening maintenance regimen

Intervention Type OTHER

whitening maintenance MW

maintenance MW

Intervention Type OTHER

negative control

negative control

Intervention Type OTHER

Other Intervention Names

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whitening maintenance regimen

Eligibility Criteria

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Inclusion Criteria

* permanent natural teeth (6-11) (22-27)
* composite lobene =\>1
* Signed Informed Consent Form
* Male and female subjects aged 18-70 years, inclusive
* Good general health and good oral health based on the opinion of the study investigator
* All maxillary anterior teeth (teeth #6 through #11) must be present;\& mandibular anterior ( Teeth #22 through 27) must be present
* Availability for the duration of the study
* Minimum average Vita Extended Bleachedguide 3D-Master shade score of 17 ≥ or darker
* A minimum mean of 1.5 ≥ determined by the Interproximal Modified Lobene (IML) Stain Index
* Demonstrate a tendency to form stain in anterior teeth/ Have high staining habits ( coffee/ wine/ tea drinker)

Exclusion Criteria

* allergies
* Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer
* Restorations on the tooth to be scored which may interfere with scoring procedures
* 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
* Concurrent participation in another clinical study
* Self-reported pregnant and/or lactating women
* History of allergies to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients
* Have dentinal sensitivity
* Taking medication within a year which could alters natural tooth color or appearance,
* Have used Professional Whitening product within a year or had a dental prophylaxis ( professional dental cleaning) within 30 days prior to the start of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Locations

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FAR Oral and Systemic Health Consulting, Inc

Costa Mesa, California, United States

Site Status

Countries

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United States

Other Identifiers

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CRO-2024-07-WHT- SPMW-BGS_ MH

Identifier Type: -

Identifier Source: org_study_id

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