In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste
Condition: Tooth Erosion
MeSH terms: Tooth Erosion
Intervention: 0.254% w/w sodium fluoride and 5% KNO3; 0.454% w/w stannous fluoride; 5% KNO3
Intervention description: Dentifrice containing 0.254% w/w sodium fluoride (1150 ppm fluoride) and 5% KNO3; plus 0.25% PVM/MA copolymer and 2.5% sodium lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 millilitres [mL] of tap water for 10 seconds before expectorating again.; Dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.; Fluoride free placebo dentifrice containing 5% KNO3 (0 ppm fluoride), 0.25% PVM/MA copolymer and 2.5% lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Tin Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking description: Laboratory sample analyst will be blinded to treatment received. All study products will be overwrapped to conceal any labelling.
The dispensing staff will not be involved in any clinical assessments or laboratory analysis during the study. Dental examiner will also be blinded to the treatment received.
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment,
      cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra
      orally using a palatal appliance and testing the remineralizing performance of the
      experimental (dentifrice containing 0.254 Percent weight by weight [%, w/w] sodium fluoride
      (1150 parts per million [ppm] fluoride) and 5% KNO3 [potassium nitrate]), comparator
      (dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) and placebo (Fluoride
      free placebo containing 5% KNO3 [0 ppm fluoride] ) dentifrices 2 and 4 hours (hrs) post
      treatment application, based on surface micro hardness measurements. This study will be
      carried out in healthy adults with a maxillary dental arch suitable for the retention of the
      palatal appliance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of a personally signed and dated informed consent.

          -  Male and female participants who, at the time of screening, are between the ages of 18
             and 65 years, inclusive.

          -  Participant who is 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 in medical
             history or oral examination.

          -  Male participant able to father children and female participant of childbearing
             potential and at risk for pregnancy must agree to use a highly effective method of
             contraception throughout the study and for 5 days after the last dose of assigned
             treatment.

          -  Good oral health without lesions of the oral cavity that could interfere with the
             study evaluations.

          -  Maxillary dental arch suitable for the retention of the palatal appliance

          -  Unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary
             flow rate of at least 0.8 mL/minute.

          -  Understands and is willing, able and likely to comply with all study procedures and
             restrictions.

        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 other studies involving investigational drug(s) within 30 days prior
             to screening visit.

          -  Participation in other studies involving investigational oral care or cosmetic
             products within 30 days prior to screening visit.

          -  Acute or chronic medical or psychiatric condition 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.

          -  Pregnant female participant (self - reported).

          -  Breastfeeding female participant.

          -  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.

          -  Medication that may interfere significantly with the saliva flow in the judgment of
             the investigator. Should new medications that may interfere with the saliva flow be
             added, a second salivary flow test will be performed.

          -  Participant with any condition that would impact on their safety or wellbeing or
             affect their ability to understand and follow study procedures and requirements.

          -  Any sign of grossly carious lesions (active), moderate or severe periodontal
             conditions, or severe tooth wear. Participant presenting at screening with minor
             caries may continue in the study if their carious lesions are repaired prior to the
             first treatment visit of the study.

          -  Wears oral appliance or orthodontia (besides participants wearing permanent lower
             retainers, which are eligible).

          -  Recent history (within the last year) of alcohol or other substance abuse. Participant
             who has previously been enrolled in this study.