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

NCT06613347 | Completed DMC

• 1 other identifier: CRO-2024-07-WHT- SPMW-BGS_ MH
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Conditions

Staining

Keywords

whitening; stains; perceptions

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

Whitening Regimen

EXPERIMENTAL

Other: whitening maintenance

Whitening MW

ACTIVE COMPARATOR

Other: whitening maintenance MW

Negative Control

PLACEBO COMPARATOR

Other: negative control

Interventions

whitening maintenance OTHER

whitening maintenance regimen

Also known as: whitening maintenance regimen

Whitening Regimen

whitening maintenance MW OTHER

maintenance MW

Whitening MW

negative control OTHER

negative control

Negative Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

FAR Oral and Systemic Health Consulting, Inc

Costa Mesa, California, 92627, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 25, 2024
• Study Start: October 7, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 20, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)