Functional Validation of Lactobacillus Containing Oral Tablet

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Disease
• Intervention / Treatment: Dietary supplement: troches

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Troches; 25 persons take one probiotic troche after each meal.	Dietary supplement: troches; Take one troche after each meal.
Placebo Comparator: Troches do not contain probiotics; 25 persons take one troche that does not contain probiotics after each meal.	Dietary supplement: troches; Take one troche after each meal.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Collaborators: Grape King Bio Ltd.
• Investigators: Study Chair: Ying-Ying Chang, National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): January 29, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Periodontal disease; Caries
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: A-BR-109-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No