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

GenMont Biotech

Status: Completed

Conditions: Gingivitis

Treatments: Other: GMNL-464 Probiotic Toothpastes; Other: GMNL-143 Probiotic Toothpastes; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04190485

KMUHIRB-F(I)-20190123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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47 participants in 2 patient groups

Placebo and GMNL-143 Probiotic Toothpastes

Experimental group

Description:

Subjects will receive placebo and GMNL-143 probiotic toothpastes.

Treatment:

Other: GMNL-143 Probiotic Toothpastes

Other: Placebo

Placebo and GMNL-464 Probiotic Toothpastes

Experimental group

Description:

Subjects will receive placebo and GMNL-464 probiotic toothpastes.

Treatment:

Other: GMNL-464 Probiotic Toothpastes

Other: Placebo