NCT04190485

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 5, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

December 3, 2019

Last Update Submit

September 20, 2023

Conditions

Gingivitis

Keywords

GingivitisProbioticToothpasteOral microbiota

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Plaque index

    0, 4, 5, 9 weeks

  • Saliva sIgA

    0, 4, 5, 9 weeks

  • Halitosis

    0, 4, 5, 9 weeks

  • Questionnaire assessment

    0, 4, 5, 9 weeks

  • Analysis of oral microbiota

    0, 4, 5, 9 weeks

Study Arms (2)

Placebo and GMNL-143 Probiotic Toothpastes

EXPERIMENTAL

Subjects will receive placebo and GMNL-143 probiotic toothpastes.

Other: PlaceboOther: GMNL-143 Probiotic Toothpastes

Placebo and GMNL-464 Probiotic Toothpastes

EXPERIMENTAL

Subjects will receive placebo and GMNL-464 probiotic toothpastes.

Other: PlaceboOther: GMNL-464 Probiotic Toothpastes

Interventions

PlaceboOTHER

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.

Placebo and GMNL-143 Probiotic ToothpastesPlacebo and GMNL-464 Probiotic Toothpastes
GMNL-143 Probiotic ToothpastesOTHER

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.

Placebo and GMNL-143 Probiotic Toothpastes
GMNL-464 Probiotic ToothpastesOTHER

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.

Placebo and GMNL-464 Probiotic Toothpastes

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (1)

  • Lee MK, Chen IH, Hsu IL, Tsai WH, Lee TY, Jhong JH, Liu BC, Huang TY, Lin FK, Chang WW, Wu JH. The impact of Lacticaseibacillus paracasei GMNL-143 toothpaste on gingivitis and oral microbiota in adults: a randomized, double-blind, crossover, placebo-controlled trial. BMC Oral Health. 2024 Apr 20;24(1):477. doi: 10.1186/s12903-024-04251-4.

    PMID: 38643116DERIVED

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Ju-Hua Wu, PhD

    Kaohsiung Medical University Chung-Ho Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 9, 2019

Study Start

February 5, 2020

Primary Completion

May 13, 2022

Study Completion

May 13, 2022

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

TW(1)