To Evaluate the Efficacy of Probiotics Toothpastes in Improvement of Gingivitis and Prevention of Periodontal Diseases Via Modulating the Oral Microbiota

  • STATUS
    Recruiting
  • days left to enroll
    34
  • participants needed
    60
  • sponsor
    GenMont Biotech Incorporation
Updated on 24 January 2021
dental caries
microbiota
periodontal disease
dental plaque
dental prophylaxis

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.

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.

Details
Condition Gingivitis
Treatment Placebo, GMNL-143 Probiotic Toothpastes, GMNL-464 Probiotic Toothpastes
Clinical Study IdentifierNCT04190485
SponsorGenMont Biotech Incorporation
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 20 yrs and 59 yrs?
Gender: Male or Female
Do you have Gingivitis?
Do you have any of these conditions: Do you have Gingivitis??
Subjects received a dental prophylaxis one week before enrollment
Subjects in age of 20-59 years old
Subjects are diagnosed with moderate to serve gingivitis. (Gingival index: 1.1-3.0)
Subjects have a minimum of 20 natural teeth

Exclusion Criteria

Subjects with immunodeficiency disease. (ex. HIV, Autoimmune disease)
Subjects have severe dental caries or mucosal lesions in oral cavity
Subjects who are undergoing orthodontic treatment
Anti-inammatory drugs or antibiotics therapy during this trial
Pregnant and nursing women
Smoking, alcohol or areca nut consumption
Use of probiotic products (not including yogurt and yogurt drink) during this trial
Use of mouthwash
Participation in another clinical study
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