Clinical Study to Evaluate the Tooth Whitening Efficacy

Clinical Study to Evaluate the Tooth Whitening Efficacy of a Colgate Toothpaste With 5% Hydrogen Peroxide and Fluoride Compared to a Toothpaste With 0% Hydrogen Peroxide and Fluoride Over a One-Week Period.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06957249

Enrollment

Registered

2025-05-04

Start date

2025-04-25

Completion date

2025-05-05

Last updated

2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Whitening

Keywords

hydrogen peroxide

Brief summary

Optic White 5%HP ActivShine TP vs Crest3D White TP (head-to-head whitening clinical) The objective of this study is to evaluate the tooth whitening efficacy of a Colgate toothpaste with 5% Hydrogen Peroxide and Fluoride compared to a toothpaste with 0% Hydrogen Peroxide and Fluoride over a one-week period.

Interventions

DRUGOptic White 5%HP ActivShine Toothpaste

0.76% MFP toothpaste

DRUGCrest3DWhite Advanced Radiant Mint Toothpaste

0.243% NaF toothpaste

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Signed Informed Consent Form; * Male and female subjects 18-70 years old, inclusive; * Good general health and good oral health based on the opinion of the study investigator; * All maxillary natural permanent anterior teeth (6-11) 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 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 a professional whitening product within one (1) year and/or had a dental prophylaxis (professional dental cleaning) within thirty (30) days prior to the start of the study

Design outcomes

Primary

Measure	Time frame	Description
Tooth color measurement	baseline, day 1, day 3, day 7	Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master® (29 tabs)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026