An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining
Condition: Oral Hygiene
MeSH terms: Tooth Discoloration
Intervention: Sodium bicarbonate/ Sodium Fluoride; Sodium fluoride; Chlorhexidine digluconate
Intervention description: Toothpaste containing sodium bicarbonate and sodium fluoride as cosmetic; Toothpaste containing sodium fluoride as cosmetic; Mouthwash containing chlorhexidine digluconate
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Listerine; Fluorides; Sodium Fluoride
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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.