Dental Plaque Removal Ability of Prototype Power Toothbrush Versus a Manual Toothbrush in Healthy Participants
Condition: Dental Plaque
MeSH terms: Dental Plaque
Intervention: Reference MTB; Reference PTB; Prototype PTB (Gum line mode); Prototype PTB (Combined mode)
Intervention description: Participants will brush their teeth with manual toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 1-timed minute under supervision of study staff.; Participants will brush their teeth with power toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute under supervision of study staff.; Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode under supervision of study staff.; Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode and 1-timed minute in "Interdental" mode under supervision of study staff.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oral Health, Dental care, Lifestyle

Summary:

      The aim of this study is to evaluate the ability of a prototype power toothbrush (PTB) versus
      a manual toothbrush in healthy, right-handed manual toothbrush (MTB) participants with no
      signs of periodontal disease or excessive recession to remove dental plaque after a single
      tooth brushing event. Prior to each treatment visit, participants will abstain from oral
      hygiene for a period of 12 hours preceding a pre-brushing dental plaque evaluation.
      Participants will then brush once under supervision for 2 minutes in 'Gum line' mode and
      1-minute in 'Interdental' mode after which re-disclosing and a post-brushing plaque
      assessment will be carried out.
    

Eligibility criteria:

        Inclusion Criteria:

        An individual must meet all the following inclusion criteria to be eligible for enrollment
        into the study:

          -  Participant provision of a 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.

          -  Participant is male or female who, at the time of screening, is between the ages of 18
             and 65 years, inclusive.

          -  A participant who is willing and able to comply with scheduled visits, treatment plan,
             and other study procedures.

          -  A participant that successfully completes the investigational device training visit,
             understands and is willing to follow product usage instructions, in the opinion of the
             investigator or designee.

          -  A participant in good general and mental health, in the opinion of the investigator or
             medically qualified designee; no clinically significant and relevant abnormalities in
             medical history or upon oral examination.

          -  A participant with good dental health based on medical history and oral soft tissue
             examination at screening.

          -  A participant with a minimum of 20 permanent gradable teeth (gradable teeth are those
             where restorative materials cover less than 25% of the tooth surface graded).

          -  For continued eligibility after the Screening visit, a participant must have a mean
             RMNPI whole mouth plaque score of ≥ 0.6 at Visit 2, 3, 4 and 5.

          -  A participant that regularly uses a manual toothbrush in their daily oral hygiene
             routine.

          -  A participant that regularly brushes their teeth with their right hand.

        Exclusion Criteria:

        An individual who meets any of the following exclusion criteria will not be eligible for
        enrollment into the study:

          -  A participant who is an employee of the investigational site, either directly involved
             in the conduct of the study or a member of their immediate family; or an employee of
             the investigational site otherwise supervised by the investigator; or, a GSK CH
             employee directly involved in the conduct of the study or a member of their immediate
             family.

          -  A participant who has participated in other studies (including non-medicinal studies)
             involving investigational product(s) within 30 days prior to study entry and/or during
             study participation.

          -  A participant with, in the opinion of the investigator or medically qualified
             designee, an 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 or medically qualified
             designee, would make the participant inappropriate for entry into this study.

          -  A participant who is a pregnant female (evidenced by positive urine pregnancy test).

          -  A participant who is a breastfeeding female.

          -  A male participant able to father children or 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 assigned treatment.

          -  A female participant who is of childbearing potential and are sexually active and at
             risk for pregnancy must agree to use a highly effective method of contraception
             consistently and correctly for the duration of the active study period and for 5 days
             after the last assigned treatment.

          -  A participant with known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          -  A participant who, in the opinion of the investigator or medically qualified designee,
             should not participate in the study.

          -  A participant unwilling or unable to comply with the following Lifestyle
             Considerations: a) Participants will be requested not to have any elective dental
             procedures including teeth professionally cleaned, excluding emergency dental
             treatment ; b)Participants will be requested not to have whitening treatment
             (including professional or at home use) during the duration of the study; c)
             Participants will not be permitted to use any other oral care products (i.e. oral
             rinses, tongue cleaners, whitening, bleaching products) besides the products supplied
             for this study; d) Eligible participants will be asked to stop using their regular
             dentifrice and toothbrush from the Screening visit for the duration of the study; e)
             Participants should abstain from interproximal cleaning (i.e. dental floss, oral
             irrigators, interdental brushes) for the duration of the study. Participants will be
             permitted to use toothpicks or floss to remove impacted food only ; f) Prior to Visit
             2, 3 and 4:Participants should abstain from all oral hygiene procedures for at least12
             hours prior to the scheduled time of their Visit 2, 3 and 4 appointments; g ) On study
             visit days (Visits 2, 3 and 4) participants must abstain from all food and drink
             (except water) at least 4 hours prior to their scheduled visits until all measurements
             have been taken. Water is permitted until 1 hour prior to investigational product
             administration; h) Participants must abstain from chewing gum and consuming
             confectionary containing xylitol (e.g. mints) at least 4 hours prior to their
             scheduled visit; i) On study visit days (Visits 2, 3 and 4) participants must abstain
             from all alcohol until all measurements have been taken; j) Participants will abstain
             from caffeine-containing products for at least 4 hours prior to their scheduled Visit
             2, 3 and 4 until all measurements have been take; k) Participant will abstain from
             smoking, chewing tobacco, or smoking E-cigarettes throughout the study.

          -  A participant who has received a dental prophylaxis within 4 weeks of Screening visit.

          -  A participant who has received teeth bleaching/whitening (including professional or at
             home use) within 8 weeks prior to Screening visit.

          -  A participant who is receiving or has received treatment for periodontal disease
             (including surgery) within 12 months of Screening.

          -  A participant who has received orthodontic therapy or scaling or root planning within
             3 months of Screening.

          -  A participant with high levels of extrinsic stain or calculus deposits which might
             interfere with dental plaque assessments.

          -  A participant that has current active caries, excessive gingival recession, severe
             gingivitis or periodontitis that may, in the opinion of the investigator, compromise
             the study or the oral health of the participant if they participate in the study.

          -  A participant with the presence of oral or peri-oral ulceration including herpetic
             lesions at the time of screening.

          -  A participant who is at risk of spasms.

          -  A participant with restorations in a poor state of repair that may, in the opinion of
             the investigator, compromise the study or the oral health of the participant if they
             participate in the study.

          -  A participant with the presence of orthodontic bands or appliances, extensive crowns,
             partial or full dentures, or fixed retainers on the maxillary or mandibular teeth.

          -  A participant with a tongue or lip piercing, or any other oral feature that could
             interfere with the usage of the toothbrush.

          -  A participant who has used antibiotic treatment within 14 days prior to Screening
             visit.

          -  A participant with diagnosed xerostomia or taking any medication that in view of the
             investigator causes xerostomia.

          -  A participant with any electronic medical devices (such as pacemakers).

          -  A participant that has used a chlorhexidine mouthwash within 14 days of Screening
             visit or used any oral care product that under the criteria of the principal
             investigator could interfere with dental plaque formation.

          -  A participant unwilling to abstain from using other oral care products besides those
             assigned to them in the study.

          -  A participant with a recent history (within past year) of alcohol or other substance
             abuse.

          -  A participant that smokes or uses chew tobacco, or regularly smokes E-cigarettes.

          -  A participant who has previously been enrolled in this study.