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

NCT04190485 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2023-09-22

No results posted yet for this study

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.

Conditions

  • Gingivitis

Interventions

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    collaborator OTHER

  • GenMont Biotech Incorporation

    lead INDUSTRY

Principal Investigators

  • Ju-Hua Wu, PhD · Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2022-05-13
Completion
2022-05-13

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04190485 on ClinicalTrials.gov