An interventional study of Placebo and GMNL-143 Probiotic Toothpastes in Gingivitis, sponsored by GenMont Biotech Incorporation. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 59 Years. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by GenMont Biotech Incorporation · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Subjects will receive placebo and GMNL-143 probiotic toothpastes.
Other: Placebo · Other: GMNL-143 Probiotic Toothpastes
Subjects will receive placebo and GMNL-464 probiotic toothpastes.
Other: Placebo · Other: GMNL-464 Probiotic Toothpastes
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.
Gingival Index
The gingivitis will be evaluated at baseline and different timepoint post-intervention by Gingival index. Gingival index for individual teeth= Total of gingival index of each tooth/No. of teeth present. The minimum score of TMQHPI is 0 (Normal gingival). The maximum score of TMQHPI is 3 (severe gingivitis).
Time frame: 0, 4, 5, 9 weeks
Plaque index
The plaque accumulation will be evaluated by Turesky-Modified of the Quigley- Hein Plaque Index(TMQHPI) and plaque index at baseline and different timepoint post-intervention. TMQHPI Index= Total score/The number surfaces examine. The minimum score of TMQHPI is 0. The maximum score of TMQHPI is 5.
Time frame: 0, 4, 5, 9 weeks
Saliva sIgA
The saliva sIgA level will be evaluated at baseline and different timepoint post-intervention by ELISA.
Time frame: 0, 4, 5, 9 weeks
Halitosis
The halitosis will be evaluated at baseline and different timepoint post-intervention by halitosis meter.
Time frame: 0, 4, 5, 9 weeks
Questionnaire assessment
The oral health will be evaluated by Oral Health Impact Profile (OHIP) questionnaire. The oral health will be evaluated by Gut Health Assessment questionnaire.The questionnaire is comprised of 26 items.The questionnaire will be evaluated at baseline and different timepoint post-intervention.
Time frame: 0, 4, 5, 9 weeks
Analysis of oral microbiota
The change in composition of oral microbiota will be evaluated at baseline and different timepoint post-intervention using real time PCR.
Time frame: 0, 4, 5, 9 weeks
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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GenMont Biotech Incorporation