Functional Validation of Lactobacillus Containing Oral Tablet

NCT04873505 | Completed

• 1 other identifier: A-BR-109-047
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Periodontal Disease

Keywords

Caries; Periodontal disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gingival index

  30 minutes

• Plaque index

  1 hour

• Plaque microorganisms

  30 minutes

Study Arms (2)

Troches

EXPERIMENTAL

25 persons take one probiotic troche after each meal.

Dietary Supplement: troches

Troches do not contain probiotics

PLACEBO COMPARATOR

25 persons take one troche that does not contain probiotics after each meal.

Dietary Supplement: troches

Interventions

troches DIETARY_SUPPLEMENT

Take one troche after each meal.

Troches; Troches do not contain probiotics

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~65 years old
• At least 20 teeth except wisdom teeth

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Grape King Bio Ltd.: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ying-Ying Chang

  National Cheng-Kung University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 5, 2021
• Study Start: October 30, 2020
• Primary Completion: January 29, 2022
• Study Completion: April 29, 2022
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)