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OpenTrials
Completed

NCT Number: NCT07225478

Clinical Study to Evaluate the Tooth Whitening Efficacy of a New NextGen In-office Whitening System

The goal of this clinical study is to evaluate how well a new in-office whitening system works to whiten teeth compared to some other commercially available in-office whitening systems.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Consumer Research Consulting, LLC

Melbourne, Florida, 32935, 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 aged 18-70 years, inclusive;
  • Good general health and good oral health based on the opinion of the study investigator;
  • All maxillary natural anterior teeth (teeth #6 through #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 oral 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 professional whitening products within one (1) year and/or had dental prophylaxis (professional dental cleaning) within thirty (30) days prior to the start of the study.

Treatment and study plan

Beaming White

Drug

25%HP gel for in office use only

Philips Zoom Professional Whitening Treatment

Combination Product

Light-Activated Whitening - Contains 25% HP gel for in-office use only

Opalescence Boost PF

Combination Product

Contains 40%HP whitening gel for in-office use only

Fluoride Toothpaste

Drug

Colgate Cavity Protection Toothpaste

Soft Manual Toothbrush

Device

Colgate Adult Extra Clean soft-bristle toothbrush

CP LED

Device

CP LED 20mA

Gingival Barrier

Device

Gingival Barrier

Primary outcomes

  1. Whitening Improvements

    Time frame: Immediately after whitening and 1 week later.

    The primary outcome variable of this study will be tooth shade whitening improvements via the Vita Extended BleachedGuide 3D-Master (29 tabs).

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2025
Registry last updated
Jan 8, 2026

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.

Published trials that share one or more normalized conditions with this study.