Functional Validation of Lactobacillus Containing Oral Tablet
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): troches
Intervention type(s): Dietary Supplement
Intervention description(s): Take one troche after each meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Caries; Periodontal disease