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

NCT07225478 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2025-09-WHT-MS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Adult Subjects

Keywords

In-Office Whitening; Dental Whitening

Outcome Measures

Primary Outcomes (1)

• Whitening Improvements

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

  Immediately after whitening and 1 week later.

Study Arms (3)

NextGen In-Office Whitening System

EXPERIMENTAL

Providers will apply NextGen in-office whitening according to detailed instructions included in Appendix XII of the protocol. This includes application of a gingival barrier, followed by application of the whitening gel to the teeth directly for 3 sessions of 15 minutes each. An LED tray will also be worn during these sessions. Afterwards, all gel, barriers and isolation will be removed. Participants will be given a toothbrush and toothbrush for home use, and instructed to brush for 2 minutes twice a day.

Drug: Beaming White; Drug: Fluoride Toothpaste; Device: Soft Manual Toothbrush; Device: CP LED; Device: Gingival Barrier

Zoom In-Office Whitening System

ACTIVE COMPARATOR

Providers will apply Zoom in-office whitening according to the manufacturer's instructions, included in Appendix XII of the protocol. This includes application of a gingival barrier, followed by application of the whitening gel to the teeth directly for 3 sessions of 15 minutes each, and use of the Philips Zoom Whitespeed Lamp. Afterwards, all gel, barriers and isolation will be removed. Participants will be given a toothbrush and toothbrush for home use, and instructed to brush for 2 minutes twice a day.

Combination Product: Philips Zoom Professional Whitening Treatment; Drug: Fluoride Toothpaste; Device: Soft Manual Toothbrush

Opalescence In-Office Whitening System

ACTIVE COMPARATOR

Providers will apply Opalescence in-office whitening according to the manufacturer's instructions, included in Appendix XII of the protocol. This includes application of a gingival barrier, followed by application of the whitening gel to the teeth directly for 3 sessions of 20 minutes each. Afterwards, all gel, barriers and isolation will be removed. Participants will be given a toothbrush and toothbrush for home use, and instructed to brush for 2 minutes twice a day.

Combination Product: Opalescence Boost PF; Drug: Fluoride Toothpaste; Device: Soft Manual Toothbrush

Interventions

Beaming White DRUG

25%HP gel for in office use only

NextGen In-Office Whitening System

Opalescence Boost PF COMBINATION_PRODUCT

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

Opalescence In-Office Whitening System

Philips Zoom Professional Whitening Treatment COMBINATION_PRODUCT

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

Zoom In-Office Whitening System

Fluoride Toothpaste DRUG

Colgate Cavity Protection Toothpaste

NextGen In-Office Whitening System; Opalescence In-Office Whitening System; Zoom In-Office Whitening System

Soft Manual Toothbrush DEVICE

Colgate Adult Extra Clean soft-bristle toothbrush

NextGen In-Office Whitening System; Opalescence In-Office Whitening System; Zoom In-Office Whitening System

CP LED DEVICE

CP LED 20mA

NextGen In-Office Whitening System

Gingival Barrier DEVICE

Gingival Barrier

NextGen In-Office Whitening System

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of orthodontic appliances and/or any anterior tooth with a prosthetic crown, veneer, or deemed non-vital;
• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Consumer Research Consulting, LLC

Melbourne, Florida, 32935, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 6, 2025
• Study Start: October 31, 2025
• Primary Completion: December 21, 2025
• Study Completion: December 21, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)