Clinical Study to Evaluate the Tooth Whitening Efficacy of a New NextGen In-office Whitening System
Not Applicable
Recruiting
- Conditions
- Health Adult Subjects
- Interventions
- Drug: Beaming WhiteCombination Product: Philips Zoom Professional Whitening TreatmentCombination Product: Opalescence Boost PFDrug: Fluoride ToothpasteDevice: Soft Manual ToothbrushDevice: CP LEDDevice: Gingival Barrier
- Registration Number
- NCT07225478
- Lead Sponsor
- Colgate Palmolive
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NextGen In-Office Whitening System Beaming White 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. NextGen In-Office Whitening System Fluoride Toothpaste 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. NextGen In-Office Whitening System Soft Manual Toothbrush 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. NextGen In-Office Whitening System CP LED 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. NextGen In-Office Whitening System Gingival Barrier 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. Zoom In-Office Whitening System Philips Zoom Professional Whitening Treatment 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. Zoom In-Office Whitening System Fluoride Toothpaste 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. Zoom In-Office Whitening System Soft Manual Toothbrush 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. Opalescence In-Office Whitening System Opalescence Boost PF 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 In-Office Whitening System Fluoride Toothpaste 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 In-Office Whitening System Soft Manual Toothbrush 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.
- Primary Outcome Measures
Name Time Method Whitening Improvements 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Consumer Research Consulting, LLC
🇺🇸Melbourne, Florida, United States
Consumer Research Consulting, LLC🇺🇸Melbourne, Florida, United StatesJohn Gallob, DMDPrincipal Investigator