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

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Health Adult Subjects

Treatments: Device: Gingival Barrier; Device: Soft Manual Toothbrush; Drug: Fluoride Toothpaste; Combination Product: Opalescence Boost PF; Combination Product: Philips Zoom Professional Whitening Treatment; Drug: Beaming White; Device: CP LED

Study type: Interventional

Funder types: Industry

Identifiers

NCT07225478

CRO-2025-09-WHT-MS

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

NextGen In-Office Whitening System

Experimental group

Description:

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.

Treatment:

Device: CP LED

Drug: Beaming White

Drug: Fluoride Toothpaste

Device: Soft Manual Toothbrush

Device: Gingival Barrier

Zoom In-Office Whitening System

Active Comparator group

Description:

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.

Treatment:

Combination Product: Philips Zoom Professional Whitening Treatment

Drug: Fluoride Toothpaste

Device: Soft Manual Toothbrush

Opalescence In-Office Whitening System

Active Comparator group

Description:

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.

Treatment:

Combination Product: Opalescence Boost PF

Drug: Fluoride Toothpaste

Device: Soft Manual Toothbrush