A Randomized, Controlled, Double-blind Clinical Trial of Surinam Cherry Dentifrice With Anti-gingivitis Properties
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In the present randomized, controlled, double-blind clinical trial, we investigated the short
      term clinical efficacy of a dentifrice containing Eugenia uniflora L. ripe fruit extract in
      preventing gingivitis in children.
    

Detailed description: 
      This was a randomized, controlled, double-blind clinical trial investigating the short term
      clinical efficacy of a dentifrice containing Eugenia uniflora L. ripe fruit extract in
      preventing gingivitis in children. The study consisted of a sample of 50 male and female
      subjects between the ages of 10 and 12 years old, who had clinical signs of gingivitis. The
      subjects were randomly assigned to one of two groups. The intervention group comprised 25
      subjects who used the dentifrice with E. uniflora L. ripe fruit hydroalcoholic extract, three
      times per day, for seven consecutive days. The control group comprised 25 subjects who used
      the control dentifrice (fluoride, 1500 ppm and triclosan, 0.3%) for seven consecutive days.

      The sample size was estimated using Fleming's single-stage procedure for phase II trials.
      With regard to the primary outcome, a response proportion of at least 50% was defined as
      being clinically significant. The type I error was set as 0.05, and the type II error was set
      at 0.1. Based on these values, a sample size of 20 individuals per trial arm would provide
      90% power (1-β) to detect any clinically relevant treatment difference of 50% or greater
      compared to baseline. Taking into consideration an attrition rate of approximately 20%, the
      final sample size per trial arm comprised 25 individuals.

      Clinical examinations were performed at baseline and after seven days of dentifrice use. The
      examination was performed by a single examiner who was adequately calibrated with a Kappa
      statistic of 0.8, which is considered to be satisfactory agreement according to Landis &
      Koch. The examination data were recorded in a specific clinical chart. The diagnosis of
      gingivitis (primary outcome) was assessed using the Gingival Bleeding Index (GBI) proposed by
      Ainamo and Bay. The accumulation of biofilm (secondary outcome) was assessed with the
      Simplified Oral Hygiene Index (OHI-S) described by Greene and Vermilion. Prior to the study,
      all of the subjects were instructed on correct tooth brushing techniques and received a kit
      that contained a toothbrush and one of the dentifrices (without the identification of its
      contents). The dentifrices were also masked with regard to flavor and color so that they
      could not be identified. In addition, the examiner had no knowledge of the subject
      allocation. Thus, the study was double-blind.

      The sample included only subjects who had not used an antimicrobial in the last two months,
      including topical fluoride.
    

Intervention name(s): Dentifrice
Intervention type(s): Drug
Intervention description(s): 3x/day for 7 days.
Other intervention name(s): Surrinam cherry dentifrice, Colgate total 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment