Clinical Study to Evaluate the Tooth Whitening Efficacy

Phase 3

Completed

• Conditions: Whitening
• Interventions: Drug: Optic White 5%HP ActivShine Toothpaste; Drug: Crest3DWhite Advanced Radiant Mint Toothpaste

• Registration Number: NCT06957249
• Lead Sponsor: Colgate Palmolive

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-25
• Study First Submitted: 2025-04-26
• Study First Submitted QC: 2025-04-26
• Status Verified: 2025-05
• Primary Completion: 2025-05-03
• Study Completion: 2025-05-03
• Last Update Submitted: 2025-05-03
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test 1 Toothpaste	Optic White 5%HP ActivShine Toothpaste	fluoride toothpaste
Test 2 Toothpaste	Crest3DWhite Advanced Radiant Mint Toothpaste	fluoride toothpaste

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Consumer Research Consulting, LLC; 🇺🇸 Melbourne, Florida, United States