NCT04873505

Functional Validation of Lactobacillus Containing Oral Tablet

Completed NA Last updated 1 June 2023

What this trial tests

NA trial testing troches in Periodontal Disease in 50 participants. Completed in 29 April 2022.

Timeline

30 October 2020

Primary endpoint
29 January 2022

29 April 2022

Quick facts

Lead sponsor	National Cheng-Kung University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	50
Start date	30 October 2020
Primary completion	29 January 2022
Estimated completion	29 April 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• troches

Conditions studied

• Periodontal Disease — all drugs for Periodontal Disease →

Sponsor

National Cheng-Kung University Hospital

Who can join

Adults 20 to 65, any sex, with Periodontal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.