Periodontal DiseaseNCT04873505
Functional Validation of Lactobacillus Containing Oral Tablet
A study testing troches in people with Periodontal Disease, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Dental caries and periodontal disease are the two most common diseases in dentistry. Caries was caused by the acidic environment produced through the interaction of oral flora (biofilm) and fermentable food residues on the tooth surface over time thus to destroying the tooth structure. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- troches
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Oct 2020to 29 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20~65 years old
- At least 20 teeth except wisdom teeth
Who cannot join
- Smoking habits
- Oral cancer or other serious oral diseases.
- Pregnancy
- Severe chronic diseases
- Coagulation diseases
- Long-term or regular use of medication (anti-epileptics, antihistamines, anti-inflammatory, sedatives, tranquilizers, analgesics, Chinese herbs)
- Allergy to test products
Trial locations and contacts
1 site in 1 country.
About this study
Dental caries and periodontal disease are the two most common diseases in dentistry. Caries was caused by the acidic environment produced through the interaction of oral flora (biofilm) and fermentable food residues on the tooth surface over time thus to destroying the tooth structure. Periodontal disease was also highly associated with microorganisms in the periodontal tissues and the inflammatory response of the host that irritate and destruct periodontal and bone tissues. Recent studies have found that both stress and eating habits are associated with decline in oral health. Probiotics have been traditionally used for prevention and treatment of gastrointestinal diseases. In the past decade, accumulated studies further indicate that imbalance of oral microflora is highly related to oral diseases thus probiotics has been suggested for maintaining oral health. It is thus conceivable that probiotics as a buccal tablet may potentially restore the balance of oral flora providing a novel strategy to combat oral diseases. Such strategy may also harbor great opportunities for the long-term management of dental caries and periodontal infections. In order to evaluate the efficacy of probiotics buccal tablet in rebalancing oral flora and control to reduce the incidence of dental caries and periodontal diseases, the investigators aimed to conduct a comprehensive clinical trials for subsequent product optimization.
Grape King Biotechnology Co., Ltd. has successfully developed oral tablet mainly composed of Lactobacillus plantarum GKD7 and Pediococcus acidilactici GKA4. These two probiotics were found to inhibit caries through producing protective biofilms thus are more effective than commercially available anti-tooth decay products. To evaluate the future potential of clinical applications of the related products series and the impact on oral health-related indicators, the investigators will explore the changes in the the following disease associated indexes before and after using the oral tablet. These include periodontal pocket depth, the gingival inflammation index, the plaque index, and the ratio of Firmicutes, Bacteroidetes, Streptococcus mutans, and Porphyromonas gigivalis, as well as quantification of total bacteria. This clinical study will be performed in Department of Stomatology in NCKUH in collaboration with periodontics session and Family Dentistry session. A total of 50 healthy individuals within the range of 20~65 years old will be enrolled.
Read the detailed description
The following parameters will be collected and analyzed: periodontal pocket depth, the gingival inflammation index, the plaque index, and the ratio of Firmicutes/ Bacteroidetes/Streptococcus mutans/Porphyromonas gigivalis, as well as total count of microorganisms from the plaque collected.
- Conditions
- Periodontal Disease
- Being tested
- troches
- Keywords
- Caries, Periodontal disease
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trochesDietary supplement
Take one troche after each meal.
| Study group | Role | What they receive |
|---|---|---|
| Troches | Experimental | 25 persons take one probiotic troche after each meal. Receives: Dietary Supplement: troches |
| Troches do not contain probiotics | Placebo comparator | 25 persons take one troche that does not contain probiotics after each meal. Receives: Dietary Supplement: troches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket depth
The probe should be walked around each tooth, and the probing depth of each tooth will be recorded in its six aspect (MB, M, DB, ML, L, DL)
Measured: 1 hour
Secondary outcomes (3)
Gingival index
The scores from the six areas of the tooth may be added and divided by six to give the GI for the tooth.
By adding the indices for the teeth and dividing by the total number of teeth examined, the Gl for the individual is obtained.
Measured: 30 minutes
Plaque index
The disclosing solution is painted on all exposed tooth surfaces. After the patient has rinsed, the operator, using an explorer or the tip of a probe, examines each stained surface for soft accumulations at the dentogingival junction. When found, they are recorded by making a dash in the appropriate spaces on the record form.Silmilar to the gingival index, each of the six gingival areas of the tooth will be examined and recorded.
The overall plaque index is calculated by dividing the number of plaque containing surfaces with the total number of available surfaces.
Measured: 1 hour
Plaque microorganisms
The ratio of Firmicutes/ Bacteroidetes/Streptococcus mutans/Porphyromonas gigivalis, as well as total count of microorganisms from the plaque collected.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start30 Oct 2020
- Primary completion29 Jan 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Responsible party
- Sponsor
- Investigators
- Ying-Ying Chang, Study chair, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873505
- Sponsor's protocol ID
- A-BR-109-047
- Status last verified
- May 2023
- First submitted
- 22 Apr 2021
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Validation of Lactobacillus Containing Oral Tablet
- ClinicalTrials.gov ID
- NCT04873505
- Acronym / sponsor ID
- A-BR-109-047
- Conditions
- Periodontal Disease
- Keywords
- Caries, Periodontal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 5 May 2021 (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.
Dental caries and periodontal disease are the two most common diseases in dentistry. Caries was caused by the acidic environment produced through the interaction of oral flora (biofilm) and fermentable food residues on the tooth surface over time thus to destroying the tooth structure. Periodontal disease was also highly associated with microorganisms in the periodontal tissues and the inflammatory response of the host that irritate and destruct periodontal and bone tissues. Recent studies have found that both stress and eating habits are associated with decline in oral health. Probiotics have been traditionally used for prevention and treatment of gastrointestinal diseases. In the past decade, accumulated studies further indicate that imbalance of oral microflora is highly related to oral diseases thus probiotics has been suggested for maintaining oral health. It is thus conceivable that probiotics as a buccal tablet may potentially restore the balance of oral flora providing a novel strategy to combat oral diseases. Such strategy may also harbor great opportunities for the long-term management of dental caries and periodontal infections. In order to evaluate the efficacy of probiotics buccal tablet in rebalancing oral flora and control to reduce the incidence of dental caries and periodontal diseases, the investigators aimed to conduct a comprehensive clinical trials for subsequent product optimization.
Grape King Biotechnology Co., Ltd. has successfully developed oral tablet mainly composed of Lactobacillus plantarum GKD7 and Pediococcus acidilactici GKA4. These two probiotics were found to inhibit caries through producing protective biofilms thus are more effective than commercially available anti-tooth decay products. To evaluate the future potential of clinical applications of the related products series and the impact on oral health-related indicators, the investigators will explore the changes in the the following disease associated indexes before and after using the oral tablet. These include periodontal pocket depth, the gingival inflammation index, the plaque index, and the ratio of Firmicutes, Bacteroidetes, Streptococcus mutans, and Porphyromonas gigivalis, as well as quantification of total bacteria. This clinical study will be performed in Department of Stomatology in NCKUH in collaboration with periodontics session and Family Dentistry session. A total of 50 healthy individuals within the range of 20~65 years old will be enrolled.
Detailed description
The following parameters will be collected and analyzed: periodontal pocket depth, the gingival inflammation index, the plaque index, and the ratio of Firmicutes/ Bacteroidetes/Streptococcus mutans/Porphyromonas gigivalis, as well as total count of microorganisms from the plaque collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Troches | Experimental | Dietary Supplement: troches25 persons take one probiotic troche after each meal. |
| Troches do not contain probiotics | Placebo comparator | Dietary Supplement: troches25 persons take one troche that does not contain probiotics after each meal. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20~65 years old
- At least 20 teeth except wisdom teeth
Key exclusion criteria (7 listed)
- Smoking habits
- Oral cancer or other serious oral diseases.
- Pregnancy
- Severe chronic diseases
- Coagulation diseases
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 |
|---|---|---|
| trochesTake one troche after each meal. | Dietary supplement | Troches, Troches do not contain probiotics |
Primary outcome
Periodontal pocket depth
Time frame: 1 hour
The probe should be walked around each tooth, and the probing depth of each tooth will be recorded in its six aspect (MB, M, DB, ML, L, DL)
3 secondary outcomes
Gingival index
Time frame: 30 minutes
Plaque index
Time frame: 1 hour
Plaque microorganisms
Time frame: 30 minutes
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 1 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Periodontal Disease
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Ying-Ying Chang study chair
National Cheng-Kung University 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 troches in people with Periodontal Disease, run by National Cheng-Kung University Hospital 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 2 inclusion and 7 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 1 Jun 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. Some participants in this study may receive a placebo. 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?
Periodontal pocket depth (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2023.