Effect of Toothpaste on the Reduction of Plaque and Inflammation
Condition: Gingivitis; Dental Plaque
MeSH terms: Gingivitis; Dental Plaque; Inflammation
Study type: Interventional

Summary: 
      The purpose of this double blind study is to prove whether a fluoride containing toothpaste
      is able to reduce dental plaque and gingival inflammation in patients who have gingivitis
      when applied twice daily during brushing at home over a period of 12 weeks.
    

Detailed description: 
      Before study start, investigators and study nurses will be trained on how to apply SOPs,
      parameters, and adverse event management. On-site monitoring will be done by the sponsor
      after recruitment, after visit 2 and after the final visit.

      All source data will be entered in paper CRFs. For the statistical analysis these data will
      be entered into the data bank via double data entry. Programmed range checks, validity
      checks, consistency checks, and manual/visual data checks for medicinal plausibility will be
      done before the blind data review meeting. During blind data review meeting minor protocol
      violations will be recorded and assessed. No imputation of missing data will be done for ITT
      or PP analyses.

      The sample size estimation was carried out by means of one-sided unpaired t-test with a
      one-sided significance level of α=0.05. For testing superiority of the test product over
      negative control, the investigators test the hypothesis, H0: μTest product - μNegative
      control ≤ 0 H1: μTest product - μNegative control > 0 by using a one-sided t-test with
      α=0.05. A relevant difference of Δ=0.14 and a standard deviation of σ=0.4 was assumed based
      on previous studies. When estimating a drop-out rate of about 20 % a total of 120 = 102 + 18
      subjects per group will be assigned at study start. Drop-outs will not be replaced during the
      study.

      The primary parameter is the difference of plaque index between baseline (V1) value and the
      value after 12 weeks +/- 5 days (V3) of product use. For primary statistical analysis, a
      t-tests (unpaired situation) will be performed at a one-sided significance level of α=0.05.
      The primary efficacy analysis will be performed on the ITT-analysis set.

      Secondary variables will be assessed with t-tests and confidence intervals to compare
      differences between V2, V3, and baseline for test product group and negative control group.
      Descriptive statistics will be performed for oral examinations for each group (counts and
      percentages of scores for nominal and ordinal scaled data, for at least ordinal scaled data
      minimum, maximum, median, mean value and standard deviation).

      A two-sided significance level of α=0.05 is chosen for all secondary analyses, no adjustment
      for multiplicity will be done. Safety assessments will be based mainly on the frequency of
      adverse events.
    

Intervention name(s): Amine fluoride; Placebo
Intervention type(s): Other; Other
Intervention description(s): toothpaste; toothpaste
Other intervention name(s): Sodium monofluorophosphate
Intervention MeSH terms: Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: clinical trial, phase III; plaque index; gingivitis index; fluoride; toothpaste