A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices
Condition: Oral Hygiene
Intervention: 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica; 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP; 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica; 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP
Intervention description: Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).; Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).; Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).; Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether spherical silica can achieve similar or
      greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing
      higher concentrations of standard abrasive silica, and how the addition of 5% sodium
      tripolyphosphate (STP) enhances cleaning capability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of a personally signed and dated informed consent document indicating that
             the participant has been informed of all pertinent aspects of the study before any
             assessment is performed.

          -  Male and female participants who, at the time of screening, are between the ages of 18
             and 65 years, inclusive.

          -  Participants who are willing and able to comply with scheduled visits, treatment plan,
             and other study procedures.

          -  Good general and mental health with, in the opinion of the investigator or medically
             qualified designee no clinically significant and relevant abnormalities of medical
             history or oral examination which could impact study outcomes.

          -  Good general and mental health with, in the opinion of the investigator or medically
             qualified designee an absence of any condition that would impact on participant safety
             or wellbeing, or affect the participant's ability to understand and follow study
             procedures and requirements.

          -  In the opinion of the investigator or medically qualified designee, at screening,
             participants must have good oral health.

          -  In the opinion of the investigator or medically qualified designee, at screening,
             participants must have at least 20 natural teeth including the 12 anterior teeth,
             gradable for Turesky Plaque Index (TPI) (Gradable teeth are those where restorative
             materials cover less than 25% of the tooth surface to be graded).

          -  In the opinion of the investigator or medically qualified designee, at screening,
             participants must have the facial surfaces of at least 4 of the anterior teeth,
             gradable for the MLSI.

          -  In the opinion of the investigator or medically qualified designee, at screening,
             participants must have the presence of extrinsic dental stain (judged to be formed due
             to dietary factors) on the facial surfaces of the anterior teeth, as determined from a
             visual MLSI stain assessment.

          -  In the opinion of the investigator, at Visit 2, participants must have a sufficient
             level of extrinsic dental stain (in the opinion of the examiner) on the facial
             surfaces of the scorable anterior (maxillary and mandibular) teeth.

          -  At Visit 3, a minimum overall pre-brushing plaque score (TPI) of ≥2.0.

        Exclusion Criteria:

          -  Participants who are investigational site staff members directly involved in the
             conduct of the study and their family members, site staff members otherwise supervised
             by the investigator, or participants who are GSK employees directly involved in the
             conduct of the study.

          -  Participation in another clinical study or receipt of an investigational drug(s)
             within 30 days prior to study entry and/or during study participation.

          -  Participants who have previously been enrolled in this study.

          -  Acute or chronic medical or psychiatric condition or laboratory abnormality that may
             increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the participant inappropriate for entry into
             this study.

          -  Any condition which, in the opinion of the investigator, causes xerostomia.

          -  Pregnant female participants.

          -  Breastfeeding female participants.

          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely
             related compounds) or any of their stated ingredients.

          -  Unwilling or unable to comply with the lifestyle guidelines described in this
             protocol.

          -  Recent history (within the last year) of alcohol or other substance abuse.

          -  Participant is unwilling to abstain from tobacco or nicotine-containing product use
             (including E-cigarettes) during the treatment evaluation period.

          -  Participants using the following mouth rinses, or taking the medications listed below:
             a) Regular use of mouthwashes containing ingredients that are known to impart
             staining. For example, chlorhexidine, essential oils or cetylpyridinium chloride
             (CPC). b) Use of a chlorhexidine, essential oil or CPC containing mouthwash within 14
             days of Visit 2 or throughout the study. c) Current use of Listerine, or any
             antimicrobial mouth rinse. d) Use of minocycline, tetracycline or doxycycline within
             30 days prior to screening. e) Use of minocycline, tetracycline or doxycycline between
             the screening and baseline visits. f) Daily doses of a medication and/or
             traditional/herbal ingredients which, in the opinion of the investigator, may affect
             study outcomes. For example, drugs or supplements containing metal ions known to
             impart staining to the enamel.

          -  Participants who have the following dental exclusions: a) Received a dental
             prophylaxis within 8 weeks of screening. b) Gross periodontal disease, treatment of
             periodontal disease (including surgery) within 12 months of screening, scaling or root
             planning within 3 months of screening. c) Dental conditions / disease requiring
             immediate treatment. d) Used any professionally dispensed or over the counter
             bleaching/ whitening products (excluding daily use whitening dentifrices) within the
             past 3 months.

          -  Participants who have the following specific dental exclusions for assessment teeth:
             a) Any tooth which, in the opinion of the investigator, appears to be non-vital based
             on changes in the intrinsic colour. b) Tooth with evidence of current or recent
             caries, or reported treatment of decay in 12 months of screening. c) Tooth with
             exposed dentine which, in the opinion of the investigator, could impact grading of
             extrinsic dental stain; tooth with deep, defective or facial restorations; tooth used
             as an abutment for fixed or removable partial dentures; tooth with full crown or
             veneer, orthodontic bands or cracked enamel. d) Tooth with surface irregularities,
             discoloration due to trauma, tetracycline stain, restorations, or hypo or hyperplasic
             areas which, in the opinion of the investigator, would prevent consistent grading of
             extrinsic dental stain. e) High levels of calculus deposits which might interfere with
             plaque assessments at the discretion of the investigator. f) Presence of orthodontic
             bands or appliances, extensive crowns, partial dentures, or fixed retainers.

          -  Any participant who, in the judgment of the investigator, should not participate in
             the study.