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

Not Applicable

Completed

• Conditions: Staining
• Interventions: Other: whitening maintenance; Other: whitening maintenance MW; Other: negative control

• Registration Number: NCT06613347
• Lead Sponsor: Colgate Palmolive

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-25
• Study Start: 2024-10-07
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whitening Regimen	whitening maintenance	-
Whitening MW	whitening maintenance MW	-
Negative Control	negative control	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

FAR Oral and Systemic Health Consulting, Inc; 🇺🇸 Costa Mesa, California, United States