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OpenTrials
Completed

NCT Number: NCT06957249

Clinical Study to Evaluate the Tooth Whitening Efficacy

Optic White 5%HP ActivShine TP vs Crest3D White TP (head-to-head whitening clinical) The objective of this study is to evaluate the tooth whitening efficacy of a Colgate toothpaste with 5% Hydrogen Peroxide and Fluoride compared to a toothpaste with 0% Hydrogen Peroxide and Fluoride over a one-week period.

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Key information

Conditions

Whitening

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Consumer Research Consulting, LLC

Melbourne, Florida, 32940, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Signed Informed Consent Form;
  • Male and female subjects 18-70 years old, inclusive;
  • Good general health and good oral health based on the opinion of the study investigator;
  • All maxillary natural permanent anterior teeth (6-11) must be present;
  • Availability for the duration of the study;
  • Minimum average Vita Extended Bleachedguide 3D-Master shade score of 17 ≥ or darker.

Exclusion criteria

  • Presence of orthodontic appliances and/or any anterior tooth with a prosthetic crown, veneer, or deemed non-vital;
  • 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 or sensitivity to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients;
  • Restorations on the teeth to be scored which may interfere with scoring procedures;
  • Have used a professional whitening product within one (1) year and/or had a dental prophylaxis (professional dental cleaning) within thirty (30) days prior to the start of the study

Treatment and study plan

Optic White 5%HP ActivShine Toothpaste

Drug

0.76% MFP toothpaste

Crest3DWhite Advanced Radiant Mint Toothpaste

Drug

0.243% NaF toothpaste

Primary outcomes

  1. Tooth color measurement

    Time frame: baseline, day 1, day 3, day 7

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

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Clinical Study to Evaluate the Tooth Whitening Efficacy of a Colgate Toothpaste With 5% Hydrogen Peroxide and Fluoride Compared to a Toothpaste With 0% Hydrogen Peroxide and Fluoride Over a One-Week Period.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 4, 2025
Registry last updated
Sep 3, 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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