Functional Validation of Lactobacillus Containing Oral Tablet

Study Overview
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Brief Summary
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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
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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.

Official Title
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Functional Validation of Lactobacillus Containing Oral Tablet

Conditions
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Periodontal Disease

Intervention / Treatment
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* Dietary Supplement: troches


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 65 years old At least 20 teeth except wisdom teeth Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Troches<br>25 persons take one probiotic troche after each meal. | Dietary Supplement: troches<br>* Take one troche after each meal.<br>|
| Placebo Comparator: Troches do not contain probiotics<br>25 persons take one troche that does not contain probiotics after each meal. | Dietary Supplement: troches<br>* Take one troche after each meal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 hour | 
| Plaque microorganisms | The ratio of Firmicutes/ Bacteroidetes/Streptococcus mutans/Porphyromonas gigivalis, as well as total count of microorganisms from the plaque collected. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal disease, Caries