Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE

JDC Tech

Status and phase: Completed; Phase 3

Conditions: Tooth Whitening

Treatments: Drug: Hydrogen Peroxide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00978861

RE5

Details and patient eligibility

About

The purpose of this study is to determine the effect of REMEWHITE on tooth whitening.

Full description

This study intended to establish the efficacy of REMEWHITE after using the product under controlled conditions at the hospital.

The efficacy of the product was assessed at the end of the study; clinical examination by the dentist.

Enrollment: 70 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ability to understand and provide informed consent
• general good health male and female adults, were 20 years or older
• no pregnant woman
• had six caines-free maxillary anterior teeth without restorations on the labial surfaces

Exclusion criteria

• had severe internal discoloration (tetracycline stains, fluorosis, pulpless teeth)
• evidence of fracture or major cracks on tooth
• were pregnant or nursing
• had tooth sensitivity
• smokers
• had teeth shade A1, A2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 1 patient group

whitening

Experimental group

Description:

30% Hydrogen peroxide

Treatment:

Drug: Hydrogen Peroxide