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.

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.

Study Overview

• Status: Completed
• Conditions: Whitening
• Intervention / Treatment: Drug: Optic White 5%HP ActivShine Toothpaste; Drug: Crest3DWhite Advanced Radiant Mint Toothpaste

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Melbourne, Florida, United States, 32940
      • Consumer Research Consulting, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1 Toothpaste; fluoride toothpaste	Drug: Optic White 5%HP ActivShine Toothpaste; 0.76% MFP toothpaste
Active Comparator: Test 2 Toothpaste; fluoride toothpaste	Drug: Crest3DWhite Advanced Radiant Mint Toothpaste; 0.243% NaF toothpaste

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: John Gallob, DMD, Consumer Research Consulting, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2025
• Primary Completion (Actual): May 3, 2025
• Study Completion (Actual): May 5, 2025

Study Registration Dates

• First Submitted: April 26, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: hydrogen peroxide
• Other Study ID Numbers: CRO-2025-04-WHT-5OW-FL-BGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes