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Completed

NCT Number: NCT06613347

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 toothpaste containing 5% Hydrogen Peroxide with a stain-fighter mouthwash as compared to only the stainfighter mouthwash and a negative control toothpaste

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Key information

Conditions

Staining

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FAR Oral and Systemic Health Consulting, Inc

Costa Mesa, California, 92627, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

whitening maintenance

Other

whitening maintenance regimen

Other names: whitening maintenance regimen

whitening maintenance MW

Other

maintenance MW

Negative Control

Other

negative control

Primary outcomes

  1. Tooth color assessment

    Time frame: Baseline

    Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)

  2. Tooth color assessment

    Time frame: 4 weeks

    Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)

  3. Tooth color assessment

    Time frame: 8 weeks

    Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)

  4. Interproximal Modified Lobene Stain Index

    Time frame: Baseline

    Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index

  5. Interproximal Modified Lobene Stain Index

    Time frame: 4 week

    Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index

  6. Interproximal Modified Lobene Stain Index

    Time frame: 8 week

    Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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