Clinical Study to Evaluate the Tooth Whitening Efficacy of a New NextGen In-office Whitening System
NCT ID: NCT07225478
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2025-10-31
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Beaming White
25%HP gel for in office use only
Fluoride Toothpaste
Colgate Cavity Protection Toothpaste
Soft Manual Toothbrush
Colgate Adult Extra Clean soft-bristle toothbrush
CP LED
CP LED 20mA
Gingival Barrier
Gingival Barrier
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.
Philips Zoom Professional Whitening Treatment
Light-Activated Whitening - Contains 25% HP gel for in-office use only
Fluoride Toothpaste
Colgate Cavity Protection Toothpaste
Soft Manual Toothbrush
Colgate Adult Extra Clean soft-bristle toothbrush
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.
Opalescence Boost PF
Contains 40%HP whitening gel for in-office use only
Fluoride Toothpaste
Colgate Cavity Protection Toothpaste
Soft Manual Toothbrush
Colgate Adult Extra Clean soft-bristle toothbrush
Interventions
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Beaming White
25%HP gel for in office use only
Philips Zoom Professional Whitening Treatment
Light-Activated Whitening - Contains 25% HP gel for in-office use only
Opalescence Boost PF
Contains 40%HP whitening gel for in-office use only
Fluoride Toothpaste
Colgate Cavity Protection Toothpaste
Soft Manual Toothbrush
Colgate Adult Extra Clean soft-bristle toothbrush
CP LED
CP LED 20mA
Gingival Barrier
Gingival Barrier
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Colgate Palmolive
INDUSTRY
Responsible Party
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Locations
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Consumer Research Consulting, LLC
Melbourne, Florida, United States
Countries
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Facility Contacts
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John Gallob, DMD
Role: primary
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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CRO-2025-09-WHT-MS
Identifier Type: -
Identifier Source: org_study_id