Health Adult SubjectsPhase 3NCT07225478

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

A Phase 3 study testing Beaming White, Philips Zoom Professional Whitening Treatment and Opalescence Boost PF in people with Health Adult Subjects, run by Colgate Palmolive at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Health Adult Subjects
What is being tested?: Beaming White, Philips Zoom Professional Whitening Treatment and Opalescence Boost PF
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2025to 21 Dec 2025
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Consumer Research Consulting, LLC
Melbourne, Florida, 32935

Other trials in United States

About this study

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
Being tested: Beaming White, Philips Zoom Professional Whitening Treatment, Opalescence Boost PF, Fluoride Toothpaste, Soft Manual Toothbrush
Keywords: In-Office Whitening, Dental Whitening

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Beaming WhiteDrug
25%HP gel for in office use only
Philips Zoom Professional Whitening TreatmentCombination product
Light-Activated Whitening - Contains 25% HP gel for in-office use only
Opalescence Boost PFCombination product
Contains 40%HP whitening gel for in-office use only
Fluoride ToothpasteDrug
Colgate Cavity Protection Toothpaste
Soft Manual ToothbrushDevice
Colgate Adult Extra Clean soft-bristle toothbrush
CP LEDDevice
CP LED 20mA
Gingival BarrierDevice
Gingival Barrier

Study groups in NCT07225478
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Combination Product: Opalescence Boost PF; Drug: Fluoride Toothpaste; Device: Soft Manual Toothbrush

What is being measured

The primary outcome is the main question the study is designed to answer.

Whitening Improvements
The primary outcome variable of this study will be tooth shade whitening improvements via the Vita Extended BleachedGuide 3D-Master (29 tabs).
Measured: Immediately after whitening and 1 week later.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 202521 Dec 2025

First posted6 Nov 2025
Study start31 Oct 2025
Primary completion21 Dec 2025
Study completion21 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Health Adult SubjectsStudies of the same condition, open and under way.
More trials run by Colgate PalmoliveThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07225478
Sponsor's protocol ID: CRO-2025-09-WHT-MS
Status last verified: Jan 2026
First submitted: 4 Nov 2025
Last updated: 8 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Evaluate the Tooth Whitening Efficacy of a New NextGen In-office Whitening System
ClinicalTrials.gov ID: NCT07225478
Acronym / sponsor ID: CRO-2025-09-WHT-MS
Conditions: Health Adult Subjects
Keywords: In-Office Whitening, Dental Whitening
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Colgate PalmoliveIndustry (pharma, biotech, devices)
Study start: 31 Oct 2025 (actual)
Primary completion: 21 Dec 2025 (actual)
Study completion: 21 Dec 2025 (actual)
First posted: 6 Nov 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
NextGen In-Office Whitening System	Experimental	Drug: Beaming White, Drug: Fluoride Toothpaste, Device: Soft Manual Toothbrush, Device: CP LED, Device: Gingival BarrierProviders 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.
Zoom In-Office Whitening System	Active comparator	Combination Product: Philips Zoom Professional Whitening Treatment, Drug: Fluoride Toothpaste, Device: Soft Manual ToothbrushProviders 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.
Opalescence In-Office Whitening System	Active comparator	Combination Product: Opalescence Boost PF, Drug: Fluoride Toothpaste, Device: Soft Manual ToothbrushProviders 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Beaming White25%HP gel for in office use only	Drug	NextGen In-Office Whitening System
Philips Zoom Professional Whitening TreatmentLight-Activated Whitening - Contains 25% HP gel for in-office use only	Combination product	Zoom In-Office Whitening System
Opalescence Boost PFContains 40%HP whitening gel for in-office use only	Combination product	Opalescence In-Office Whitening System
Fluoride ToothpasteColgate Cavity Protection Toothpaste	Drug	NextGen In-Office Whitening System, Opalescence In-Office Whitening System, Zoom In-Office Whitening System
Soft Manual ToothbrushColgate Adult Extra Clean soft-bristle toothbrush	Device	NextGen In-Office Whitening System, Opalescence In-Office Whitening System, Zoom In-Office Whitening System
CP LEDCP LED 20mA	Device	NextGen In-Office Whitening System
Gingival BarrierGingival Barrier	Device	NextGen In-Office Whitening System

Primary outcome

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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whitening Improvements (time frame: Immediately after whitening and 1 week later.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07225478.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.