An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Oral Hygiene

Treatments: Drug: Chlorhexidine digluconate; Other: Sodium fluoride; Other: Sodium bicarbonate/ Sodium Fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01962493

202182

RH01913 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to compare the stain effect on teeth of twice daily brushing with a 67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.

Enrollment: 160 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Good oral health in the opinion of the investigator (excluding gingivitis)
• A minimum of 11 of the 12 permanent gradable anterior teeth at screening
• Stain levels on the buccal surfaces of the 6 maxillary and 6 mandibular anterior teeth need to be at least "mild" and present on a minimum of 4 teeth
• Modification of the Lobene Stain Index - At Visit 2, a baseline total MLSI Intensity x Area score (four sites per tooth) of greater than or equal to 8 for facial surfaces of anterior teeth.

Exclusion criteria

• Pregnant women or women who are intending to become pregnant over the duration of the study
• Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds).
• Current use of Chlorhexidine, Cetylpyridinium Chloride or any marketed mouthwash
• Past or current use of any drug which is known to be associated with tooth discolouration within 30 days of screening or during the study period.
• Recent history (within the last 1 year) of alcohol or other substance abuse
• Dental conditions / disease requiring immediate treatment; Crowns or veneers on more than one anterior tooth; pre-existing sensitivity to oral care products; severe periodontitis; severe recession; dental implants; active carious lesions on anterior teeth; oral lesions/manifestations; prone to aphthous stomatitis and ulceration etc.
• Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study.
• Medical condition which would require the use of prophylactic antibiotics prior to dental cleanings
• Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study treatment or procedures in the opinion of the investigator or dental assessor.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 3 patient groups

Sodium bicarbonate/ Sodium Fluoride toothpaste

Other group

Description:

Marketed Sodium bicarbonate toothpaste containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)

Treatment:

Other: Sodium bicarbonate/ Sodium Fluoride

Sodium fluoride toothpaste

Active Comparator group

Description:

Non-sodium bicarbonate toothpaste containing 1450ppm fluoride as NaF

Treatment:

Other: Sodium fluoride

Chlorhexidine digluconate mouthwash

Other group

Description:

0.2% w/v Chlorhexidine digluconate mouthwash for rinsing post-brushing with study toothpastes

Treatment:

Drug: Chlorhexidine digluconate