To Evaluate the Efficacy of Probiotics Toothpastes in Improvement of Gingivitis and Prevention of Periodontal Diseases Via Modulating the Oral Microbiota
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      Gingivalis is the one of the most common diseases of oral cavity, and affects more than 75%
      of adult populations worldwide. The present studies demonstrated that the addition of
      probiotics in toothpastes or mouthwashes could reduce dental plaques and gum inflammation,
      and improve oral health. This study was designed to assess the effectiveness of probiotic
      toothpastes during the supportive therapy of moderate to sever gingivalis patients.
    

Detailed description: 
      Previous studies have shown that probiotics could improve oral health including periodontal
      diseases, dental caries and halitosis via inhibiting periodontal pathogens, modulating
      periodontal microbiome, and regulating oral mucosal immunity. Heat-killed probiotics strain,
      Lactobacillus paracasei GMNL-143 or Lactobacillus rhamnosus GMNL-464 possessed great
      coaggregation abilities with oral pathogens and removed them after rinsing mouths. Besides,
      GMNL-143 can decrease the secretion of pro-inflammatory cytokines, increase the expression of
      anti-inflammatory cytokines, and inhibit the growth of dental pathogen Streptococcus mutans.
      Hence, it is suggested GMNL-143 or GMNL-464 probiotic toothpastes can ameliorate oral health
      of patients with gingivitis.

      In this clinical study, the effectiveness of probiotic toothpastes during the supportive
      therapy of moderate to sever gingivalis patients will be clarified. A randomized,
      double-blind, crossover and placebo controlled clinical trial will be formed. This clinical
      trial will be conducted at Kaohsiung Medical University Chung-Ho Memorial Hospital,
      Kaohsiung, Taiwan. 60 subjects with moderate to severe gingivitis will be enrolled. This
      trial will last for 9 weeks, starting from the time when the subjects begin to use probiotic
      toothpastes. Subjects who pass the screening phase will enter the first visit (week 0) and
      return in the 4th, 5th and 9th weeks. Subjects will be randomized to one of two groups, using
      probiotic toothpastes (GMNL-143 or GMNL-464) or placebo toothpastes to brush teeth for two
      minutes twice daily for 4 weeks, and then will enter a 1 week-washout and afterward will be
      crossed over to the opposite treatment for 4 weeks. Subjects will receive assessments of
      plaque index and gingivitis index, collection of samples including plaque, gingival cervical
      fluid and saliva, and questionnaires of oral health impact profile (OHIP) and
      gastrointestinal health at each visit.
    

Intervention name(s): Placebo; GMNL-143 Probiotic Toothpastes; GMNL-464 Probiotic Toothpastes
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will be randomized to one of two groups, using placebo toothpastes for 4 weeks, and then will enter a 1 week-washout and afterward will be crossed over to the opposite treatment for 4 weeks.; Subjects will be randomized to one of two groups, using GMNL-143 probiotic toothpastes toothpastes for 4 weeks, and then will enter a 1 week-washout and afterward will be crossed over to the opposite placebo for 4 weeks.; Subjects will be randomized to one of two groups, using GMNL-464 probiotic toothpastes for 4 weeks, and then will enter a 1 week-washout and afterward will be crossed over to the opposite placebo for 4 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Gingivitis; Probiotic; Toothpaste; Oral microbiota