In-Office Whitening System for Tooth Discoloration

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Colgate Palmolive

Disqualifiers: Orthodontic appliances, Periodontal disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new in-office teeth whitening system called NextGen to evaluate its effectiveness compared to other popular options like Opalescence and Zoom. The study aims to determine which system whitens teeth more effectively. Participants will receive treatments directly on their teeth and compare results. Suitable candidates have natural front teeth, good oral health, and have not used professional whitening products in the past year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the approval of a potentially effective new whitening system.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on dental health and whitening products, so it's best to ask the study team for guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the NextGen In-office Whitening System is generally safe. Studies have found that tooth sensitivity is the most common side effect, causing temporary tingling or discomfort in some users. This is common with many teeth whitening products.

The NextGen system is currently in a late-stage trial, indicating some evidence of safety from earlier tests. However, individual experiences may vary. Prospective participants should discuss any concerns with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the NextGen In-Office Whitening System because it combines traditional whitening gel with an innovative LED tray, potentially enhancing the whitening effect in less time. Unlike typical in-office whitening treatments like Opalescence or Zoom, which involve longer or similar application times, NextGen reduces each session to just 15 minutes. This shorter treatment time, coupled with the LED technology, could mean quicker results for patients seeking brighter smiles.

What evidence suggests that this trial's whitening systems could be effective for tooth discoloration?

Research shows that in-office teeth whitening systems, such as the NextGen In-office Whitening System, can effectively whiten teeth. Studies have found that systems using hydrogen peroxide, like NextGen, noticeably lighten teeth quickly. Early results suggest that NextGen's use of an LED tray enhances its whitening power. This trial will compare the NextGen system to other systems, such as Opalescence and Zoom, tested in separate treatment arms. In-office treatments can deliver visible results in just a few sessions. Overall, these treatments are designed to safely provide a brighter smile. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-70 with natural front teeth (teeth #6 through #11) and a certain level of tooth darkness. They must be in good general and oral health, not pregnant or lactating, without allergies to whitening products, and have no recent dental cleanings or whitening treatments.

Inclusion Criteria

Signed Informed Consent Form

Good general health and good oral health based on the opinion of the study investigator

Availability for the duration of the study

Exclusion Criteria

Presence of orthodontic appliances and/or any anterior tooth with a prosthetic crown, veneer, or deemed non-vital

Concurrent participation in another oral clinical study

Self-reported pregnant and/or lactating women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive in-office whitening treatment using different systems, including Opalescence, NextGen, and Zoom, with sessions involving application of whitening gel and use of LED or lamp devices.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for tooth shade whitening improvements immediately after treatment and 1 week later.

1 week

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NextGen In-office Whitening System

Trial Overview The study tests the effectiveness of a new NextGen in-office tooth whitening system against other commercial systems. Participants will use various products like Beaming White, Philips Zoom, Opalescence Boost PF, along with standard tools like soft brushes and fluoride toothpaste.

How Is the Trial Designed?

Group I: NextGen In-Office Whitening System Experimental Treatment 5 Interventions

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.

Group II: Opalescence In-Office Whitening System Active Control 3 Interventions

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.

Group III: Zoom In-Office Whitening System Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

Colgate Palmolive

Lead Sponsor

Trials

106

Recruited

19,100+

Noel Wallace

Colgate Palmolive

Chief Executive Officer since 2019

MBA from Harvard Business School

Diana Haussling

Colgate Palmolive

Chief Marketing Officer since 2022

Bachelor's degree in Marketing

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07225478

Clinical Study to Evaluate the Tooth Whitening Efficacy of a ... 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/df987f277375515b/nct07225478-clinical-study-tooth-whitening-nextgen-system

Clinical Study to Evaluate the Tooth Whitening Efficacy of a ... 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 commerciall...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11672885/

Evaluation of the Effectiveness of Different Types ... This review aimed to evaluate the greater effectiveness of in-office, at-home, and combined bleaching with hydrogen or carbamide peroxide.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1572100021003562

Evaluation of the effectiveness in teeth whitening of a ... This study aimed to compare the effectiveness and sensitivity of in-office dental bleaching with one versus two applications of 6% hydrogen peroxide (HP) gel

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12011655/

Clinical evaluation of in-office bleaching with low, medium ... The study evaluated the longevity, efficacy, sensitivity, and impact on the oral health-related quality of life of in-office dental bleaching

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/78/NCT07225478/Prot_SAP_ICF_000.pdf

"APPROVED Study Title: Clinical Study to Evaluate the Tooth Whitening Efficacy of a new NextGen in-office whitening system. Principal Investigator: Dr ...

7. researchgate.net researchgate.net/publication/264984792_In-Office_Tooth_Whitening_Pulpal_Effects_and_Tooth_Sensitivity_Issues

Pulpal Effects and Tooth Sensitivity Issues The efficacy and side effects are dependent on the technique, with tooth sensitivity being the most commonly reported side effect associated ...

8. mdpi.com mdpi.com/2306-5354/11/12/1178

Evaluation of the Effectiveness of Different Types ... This review aimed to evaluate the greater effectiveness of in-office, at-home, and combined bleaching with hydrogen or carbamide peroxide.