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

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

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

Study Overview

• Status: Completed
• Conditions: Staining
• Intervention / Treatment: Other: whitening maintenance; Other: whitening maintenance MW; Other: negative control

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92627
      • FAR Oral and Systemic Health Consulting, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Negative Control	Other: negative control; negative control
Experimental: Whitening Regimen	Other: whitening maintenance; whitening maintenance regimen; Other Names: whitening maintenance regimen
Active Comparator: Whitening MW	Other: whitening maintenance MW; maintenance MW

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tooth color assessment	Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)	Baseline
Tooth color assessment	Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)	4 weeks
Tooth color assessment	Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)	8 weeks
Interproximal Modified Lobene Stain Index	Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index	Baseline
Interproximal Modified Lobene Stain Index	Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index	4 week
Interproximal Modified Lobene Stain Index	Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index	8 week

Collaborators and Investigators

• Sponsor: Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: whitening; perceptions; stains
• Other Study ID Numbers: CRO-2024-07-WHT- SPMW-BGS_ MH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will report only results as aggregate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No