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

January 7, 2026 updated by: Colgate Palmolive
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Melbourne, Florida, United States, 32935
        • Consumer Research Consulting, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NextGen In-Office Whitening System
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
25%HP gel for in office use only
Drug: Fluoride Toothpaste
Colgate Cavity Protection Toothpaste
Device: Soft Manual Toothbrush
Colgate Adult Extra Clean soft-bristle toothbrush
Device: CP LED
CP LED 20mA
Device: Gingival Barrier
Gingival Barrier
Active Comparator: Zoom In-Office Whitening System
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.
Drug: Fluoride Toothpaste
Colgate Cavity Protection Toothpaste
Device: Soft Manual Toothbrush
Colgate Adult Extra Clean soft-bristle toothbrush
Combination product: Philips Zoom Professional Whitening Treatment
Light-Activated Whitening - Contains 25% HP gel for in-office use only
Active Comparator: Opalescence In-Office Whitening System
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.
Drug: Fluoride Toothpaste
Colgate Cavity Protection Toothpaste
Device: Soft Manual Toothbrush
Colgate Adult Extra Clean soft-bristle toothbrush
Combination product: Opalescence Boost PF
Contains 40%HP whitening gel for in-office use only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Immediately after whitening and 1 week later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2025

Primary Completion (Actual)

December 21, 2025

Study Completion (Actual)

December 21, 2025

Study Registration Dates

First Submitted

November 4, 2025

First Submitted That Met QC Criteria

November 4, 2025

First Posted (Estimated)

November 6, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRO-2025-09-WHT-MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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