A Study Comparing the Interproximal Plaque and Gingivitis Effects of Three Interdental Cleaning Modalities
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The purpose of this research study is to compare the interproximal plaque removal ability of
      Philips Sonicare Interproximal Cleaning Device to floss (Crest Glide) and Waterpik
      Waterflosser. In addition, we seek to learn more about the results of using this device on
      plaque accumulation and what biological processes influence the makeup of plaque and
      reduction of gingivitis.
    

Detailed description: 
      Primary Endpoint The primary endpoint of this study is the residual protein concentration in
      posterior sites following single use treatment with either manual toothbrush, manual
      toothbrush + Sonicare IP cleaning prototype, manual toothbrush + Waterpik Ultra Water Flosser
      or manual toothbrush + floss.

      Secondary Endpoints Gingival bleeding index and Modified gingival index following single use
      treatment with either MTB, MTB + IP cleaning prototype, MTB + Waterpik Waterflosser or MTB +
      floss.

      Comparisons of the concentration levels of 272 different pathogens between treatment groups

      Biomarker profiles following the different treatment modalities

      Safety endpoints based on adverse events and intraoral exam (soft tissue evaluation).

      IP cleaning satisfaction questionnaire following treatment with either MTB, MTB + IP cleaning
      prototype, MTB + Waterpik Waterflosser or MTB + floss.

      Expected Duration of Study The planned duration of a subject's participation in this study is
      approximately 2 weeks.

      Discontinuation Criteria/Stopping Rules If in the opinion of the investigator, the health or
      safety of a subject is affected adversely by participation in the study or non-compliance to
      at-home oral hygiene regimen adversely effects test product familiarization or plaque
      regrowth, the subject will be removed.

      Controls to Minimize Bias All eligible subjects will be randomized at Visit 1. Randomization
      of Subjects and Balance of Test Groups Subjects will be randomized to one of the four
      treatment groups according to a 1:1:1:1 ratio. Randomization will be stratified by gender to
      complete with approximately 68 subjects.

      Blinding The examiner and laboratory personnel will be blinded.

      Maintenance of randomization Codes In order to minimize bias, this study will be randomized
      and single blind - the Examiners performing the interproximal plaque sampling and gingivitis
      assessment are the designated blinded personnel. Unblinding of study data will not occur
      until after all study procedures have been completed.

      Experimental Regimen and Product Labeling The devices used in this study are subject only to
      Class I (general controls) and considered exempt from the premarket notification procedures
      and not subject to section 510(k), 515, or 520(m,) of the FDC Act in order to be legally
      marketed. Thus, the study does not meet the definition of an Applicable Clinical Trial.

      Each subject will receive an ADA Reference manual toothbrush, timer, dentifrice and, if
      assigned, an IP cleaning device (either Sonicare Prototype, Crest Glide Floss or Waterpik
      Ultra Water Flosser (WP 100) with the Classic Jet Tip). Subjects are to brush twice daily for
      two minutes and, if assigned, use their IP cleaning device once daily, in the evening, after
      toothbrushing. The Directions for Use for all devices can be found in the protocol Appendices
      and should be reviewed with the subjects who shall demonstrate proper usage at the time of
      product assignment.

      Methods and Treatments not Permitted on Study Once enrolled on-study, the use of any
      additional oral hygiene treatments and aids other than those prescribed is prohibited. A list
      of prohibited devices and aids includes but is not limited to mouthwash, chewing gum,
      whitening products, non-assigned interproximal cleaning aids/devices or breath films. The use
      of any dentifrice other than that dispensed at Visit 2 is prohibited. In the event that an
      enrolled subject requires dental care outside the scope of the study, he/she will be
      discontinued from the trial.

      The use of antibiotics or antibacterial agents while participating on the study is also
      prohibited and subjects who are required to use them will be removed from the dataset for
      endpoint analysis. The use of prescription strength and repeat dose of non-steroidal
      anti-inflammatories and anticoagulants (including Aspirin) for longer than 2 days is also
      prohibited.

      All deviations from the prescribed treatment will be documented and continued eligibility
      will be reassessed.

      Determination of Sample Size Sample size justification is based on considerations of
      statistical power for detecting a difference in mean residual protein concentration (RPC)
      between the manual toothbrush group and the manual toothbrush + Sonicare Interproximal (IP)
      Cleaning Prototype group. A sample size of 17 per group at visit 3 (the anticipated sample
      size after allowance for dropout) will provide 80% power for detecting a difference in mean
      RPC between groups of 4.71 (µg/ml) assuming a subject-level standard error of the average of
      two RPC measurements of 4.76 (the square of this standard error is the variance determined
      from assuming an RPC IP site-specific standard deviation of 6.15, and an intramouth
      correlation of the two RPC measurements of 0.2, as estimated from a statistical model (see
      8.6) for preliminary data that adjusts for baseline RPC).
    

Intervention name(s): Sonicare Interproximal (IP) Cleaning Prototype
Intervention type(s): Other
Intervention description(s): Sonicare Interproximal (IP) Cleaning Prototype used to clean between the teeth 1 time a day in combination with brushing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment