Clinical Study to Assess the Efficacy of Professional Tooth Whitening Maintenance System

Colgate-Palmolive

Status: Completed

Conditions: Staining

Treatments: Other: whitening maintenance MW; Other: whitening maintenance; Other: negative control

Study type: Interventional

Funder types: Industry

Identifiers

NCT06613347

CRO-2024-07-WHT- SPMW-BGS_ MH

Details and patient eligibility

About

Clinical study to assess the efficacy of professional tooth whitening maintenance system of a Colgate toothpaste containing 5% Hydrogen Peroxide with a stain-fighter mouthwash as compared to only the stainfighter mouthwash and a negative control toothpaste

Enrollment: 93 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• permanent natural teeth (6-11) (22-27)
• composite lobene =>1
• Signed Informed Consent Form
• Male and female subjects aged 18-70 years, inclusive
• Good general health and good oral health based on the opinion of the study investigator
• All maxillary anterior teeth (teeth #6 through #11) must be present;& mandibular anterior ( Teeth #22 through 27) must be present
• Availability for the duration of the study
• Minimum average Vita Extended Bleachedguide 3D-Master shade score of 17 ≥ or darker
• A minimum mean of 1.5 ≥ determined by the Interproximal Modified Lobene (IML) Stain Index
• Demonstrate a tendency to form stain in anterior teeth/ Have high staining habits ( coffee/ wine/ tea drinker)

Exclusion criteria

• allergies
• Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer
• Restorations on the tooth to be scored which may interfere with scoring procedures
• 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 to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients
• Have dentinal sensitivity
• Taking medication within a year which could alters natural tooth color or appearance,
• Have used Professional Whitening product within a year or had a dental prophylaxis ( professional dental cleaning) within 30 days prior to the start of the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 3 patient groups, including a placebo group

Whitening Regimen

Experimental group

Treatment:

Other: whitening maintenance

Whitening MW

Active Comparator group

Treatment:

Other: whitening maintenance MW

Negative Control

Placebo Comparator group

Treatment:

Other: negative control