Clinical Study to Evaluate the Tooth Whitening Efficacy

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Whitening

Treatments: Drug: Crest3DWhite Advanced Radiant Mint Toothpaste; Drug: Optic White 5%HP ActivShine Toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT06957249

CRO-2025-04-WHT-5OW-FL-BGS

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups

Test 1 Toothpaste

Experimental group

Description:

fluoride toothpaste

Treatment:

Drug: Optic White 5%HP ActivShine Toothpaste

Test 2 Toothpaste

Active Comparator group

Description:

fluoride toothpaste

Treatment:

Drug: Crest3DWhite Advanced Radiant Mint Toothpaste