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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07225478
Enrollment
180
Registered
2025-11-06
Start date
2025-10-31
Completion date
2025-12-21
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Adult Subjects

Keywords

In-Office Whitening, Dental Whitening

Brief summary

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.

Interventions

DRUGBeaming White

25%HP gel for in office use only

COMBINATION_PRODUCTPhilips Zoom Professional Whitening Treatment

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

COMBINATION_PRODUCTOpalescence Boost PF

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

DRUGFluoride Toothpaste

Colgate Cavity Protection Toothpaste

Colgate Adult Extra Clean soft-bristle toothbrush

DEVICECP LED

CP LED 20mA

DEVICEGingival Barrier

Gingival Barrier

Sponsors

Colgate Palmolive
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Whitening ImprovementsImmediately 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026