Clinical Study to Evaluate the Tooth Whitening Efficacy

NCT06957249 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2025-04-WHT-5OW-FL-BGS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Whitening

Keywords

hydrogen peroxide

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test 1 Toothpaste

EXPERIMENTAL

fluoride toothpaste

Drug: Optic White 5%HP ActivShine Toothpaste

Test 2 Toothpaste

ACTIVE COMPARATOR

fluoride toothpaste

Drug: Crest3DWhite Advanced Radiant Mint Toothpaste

Interventions

Optic White 5%HP ActivShine Toothpaste DRUG

0.76% MFP toothpaste

Test 1 Toothpaste

Crest3DWhite Advanced Radiant Mint Toothpaste DRUG

0.243% NaF toothpaste

Test 2 Toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Consumer Research Consulting, LLC

Melbourne, Florida, 32940, United States

Location

Study Officials

• John Gallob, DMD

  Consumer Research Consulting, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: April 25, 2025
• Primary Completion: May 3, 2025
• Study Completion: May 5, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)