Clinical Study to Evaluate the Tooth Whitening Efficacy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2025-05-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Whitening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test 1 Toothpaste

fluoride toothpaste

Group Type EXPERIMENTAL

Optic White 5%HP ActivShine Toothpaste

Intervention Type DRUG

0.76% MFP toothpaste

Test 2 Toothpaste

fluoride toothpaste

Group Type ACTIVE_COMPARATOR

Crest3DWhite Advanced Radiant Mint Toothpaste

Intervention Type DRUG

0.243% NaF toothpaste

Interventions

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Optic White 5%HP ActivShine Toothpaste

0.76% MFP toothpaste

Intervention Type DRUG

Crest3DWhite Advanced Radiant Mint Toothpaste

0.243% NaF toothpaste

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes