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

Gingivitis Clinical Trial

Official title:

To Evaluate the Clinical Efficacy of the Probiotic Toothpastes in Patients With Moderate to Severe Gingivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190485
• Other study ID #: KMUHIRB-F(I)-20190123
• Status: Completed
• Phase: N/A
• Start date: February 5, 2020
• Est. completion date: May 13, 2022

Study information

• Verified date: September 2023
• Source: GenMont Biotech Incorporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 13, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

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-in?ammatory 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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Other:
• Placebo
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.
• GMNL-143 Probiotic Toothpastes
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.
• GMNL-464 Probiotic Toothpastes
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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
GenMont Biotech Incorporation	Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	0, 4, 5, 9 weeks
Secondary	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.	0, 4, 5, 9 weeks
Secondary	Saliva sIgA	The saliva sIgA level will be evaluated at baseline and different timepoint post-intervention by ELISA.	0, 4, 5, 9 weeks
Secondary	Halitosis	The halitosis will be evaluated at baseline and different timepoint post-intervention by halitosis meter.	0, 4, 5, 9 weeks
Secondary	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.	0, 4, 5, 9 weeks
Secondary	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.	0, 4, 5, 9 weeks