Clinical trial NCT04190485: To Evaluate the Efficacy of Probiotics Toothpastes in Improvement of Gingivitis and Prevention of Periodontal Diseases Via Modulating the Oral Microbiota
Official title: To Evaluate the Clinical Efficacy of the Probiotic Toothpastes in Patients With Moderate to Severe Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: Gingivitis
Probiotic
Toothpaste
Oral microbiota
Lead sponsor: GenMont Biotech Incorporation
Sponsor class: INDUSTRY
Collaborators: name: Kaohsiung Medical University Chung-Ho Memorial Hospital
First posted: 2019-12-09
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects received a dental prophylaxis one week before enrollment.
2. Subjects in age of 20-59 years old.
3. Subjects are diagnosed with moderate to serve gingivitis. (Gingival index: 1.1-3.0)
4. Subjects have a minimum of 20 natural teeth.

Exclusion Criteria:

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

Primary outcomes:
measure: Gingival Index
timeFrame: 0, 4, 5, 9 weeks
Secondary outcomes:
measure: Plaque index
timeFrame: 0, 4, 5, 9 weeks
measure: Saliva sIgA
timeFrame: 0, 4, 5, 9 weeks
measure: Halitosis
timeFrame: 0, 4, 5, 9 weeks
measure: Questionnaire assessment
timeFrame: 0, 4, 5, 9 weeks
measure: Analysis of oral microbiota
timeFrame: 0, 4, 5, 9 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Ju-Hua Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: