GingivitisNCT04190485
To Evaluate the Efficacy of Probiotics Toothpastes in Improvement of Gingivitis and Prevention of Periodontal Diseases Via Modulating the Oral Microbiota
A study testing GMNL-143 Probiotic Toothpastes and GMNL-464 Probiotic Toothpastes in people with Gingivitis, run by GenMont Biotech Incorporation at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- GMNL-143 Probiotic Toothpastes and GMNL-464 Probiotic Toothpastes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Feb 2020to 13 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Use of probiotic products (not including yogurt and yogurt drink) during this trial.
- Use of mouthwash.
- Participation in another clinical study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
About this study
Official title: To Evaluate the Clinical Efficacy of the Probiotic Toothpastes in Patients With Moderate to Severe Gingivitis
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.
Read the 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.
- Conditions
- Gingivitis
- Being tested
- Placebo, GMNL-143 Probiotic Toothpastes, GMNL-464 Probiotic Toothpastes
- Keywords
- Gingivitis, Probiotic, Toothpaste, Oral microbiota
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo and GMNL-143 Probiotic Toothpastes | Experimental | Subjects will receive placebo and GMNL-143 probiotic toothpastes. Receives: Other: Placebo; Other: GMNL-143 Probiotic Toothpastes |
| Placebo and GMNL-464 Probiotic Toothpastes | Experimental | Subjects will receive placebo and GMNL-464 probiotic toothpastes. Receives: Other: Placebo; Other: GMNL-464 Probiotic Toothpastes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0, 4, 5, 9 weeks
Secondary outcomes (5)
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.
Measured: 0, 4, 5, 9 weeks
Saliva sIgA
The saliva sIgA level will be evaluated at baseline and different timepoint post-intervention by ELISA.
Measured: 0, 4, 5, 9 weeks
Halitosis
The halitosis will be evaluated at baseline and different timepoint post-intervention by halitosis meter.
Measured: 0, 4, 5, 9 weeks
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.
Measured: 0, 4, 5, 9 weeks
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.
Measured: 0, 4, 5, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start5 Feb 2020
- Primary completion13 May 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenMont Biotech Incorporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ju-Hua Wu, PhD, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190485
- Sponsor's protocol ID
- KMUHIRB-F(I)-20190123
- Status last verified
- Sep 2023
- First submitted
- 3 Dec 2019
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38643116
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Clinical Efficacy of the Probiotic Toothpastes in Patients With Moderate to Severe Gingivitis
- ClinicalTrials.gov ID
- NCT04190485
- Acronym / sponsor ID
- KMUHIRB-F(I)-20190123
- Conditions
- Gingivitis
- Keywords
- Gingivitis, Probiotic, Toothpaste, Oral microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- GenMont Biotech IncorporationIndustry (pharma, biotech, devices)
- Collaborators
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo and GMNL-143 Probiotic Toothpastes | Experimental | Other: Placebo, Other: GMNL-143 Probiotic ToothpastesSubjects will receive placebo and GMNL-143 probiotic toothpastes. |
| Placebo and GMNL-464 Probiotic Toothpastes | Experimental | Other: Placebo, Other: GMNL-464 Probiotic ToothpastesSubjects will receive placebo and GMNL-464 probiotic toothpastes. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSubjects 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 | Placebo and GMNL-143 Probiotic Toothpastes, Placebo and GMNL-464 Probiotic Toothpastes |
| GMNL-143 Probiotic ToothpastesSubjects 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 | Placebo and GMNL-143 Probiotic Toothpastes |
| GMNL-464 Probiotic ToothpastesSubjects 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. | Other | Placebo and GMNL-464 Probiotic Toothpastes |
Primary outcome
Gingival Index
Time frame: 0, 4, 5, 9 weeks
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).
5 secondary outcomes
Plaque index
Time frame: 0, 4, 5, 9 weeks
Saliva sIgA
Time frame: 0, 4, 5, 9 weeks
Halitosis
Time frame: 0, 4, 5, 9 weeks
Questionnaire assessment
Time frame: 0, 4, 5, 9 weeks
Analysis of oral microbiota
Time frame: 0, 4, 5, 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 38643116Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Hua Wu, PhD principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GMNL-143 Probiotic Toothpastes and GMNL-464 Probiotic Toothpastes in people with Gingivitis, run by GenMont Biotech Incorporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Index (time frame: 0, 4, 5, 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04190485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.