Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate beneficial effects of probiotic Lactobacillus brevis
      CD2 tablets in addition to the primary treatment for patients with chronic periodontitis
      (Full Mouth Disinfection), at local level and at systemic level.
    

Detailed description: 
      This study will be conducted as a double blind, randomized, parallel group, placebo
      controlled clinical trial, involving subjects of 21 years of age or older to evaluate the
      beneficial effects of INERSAN® tablets as the primary treatment for patients with chronic
      periodontitis.

      Patients satisfying the "Inclusion criteria" will be enrolled into the study after explaining
      them the objective of the study and after taking their written consent.

      The probiotic tablets used in the present study contain a single strain of Lactobacilli,
      Lactobacillus brevis CD2, as active component. The placebo will be a mix of sugars and salts
      used as excipients in the active formulation. The active study medication and Placebo will be
      identical in appearance and organoleptic properties. Study treatment will be started from the
      day of enrollment and continued for 6 weeks. The daily dose of trial product will be 5
      tablets per day, one tablet to be taken every 2-3 hours. The tablets will be to be kept in
      mouth for it to dissolve by itself. A hot beverage (e.g.: tea, coffee, milk etc.) will not to
      be taken for at least half an hour before and after the medication since elevated temperature
      could inactivate the bacteria.

      The study drug and placebo will be provided as per the randomization schedule, packed in
      patient specific packs, bearing patient number. The study being a double masked study, both
      the patient and the Investigator will be blinded during the entire course of the trial. A
      sealed copy of the randomization codes will be given to the Principal Investigator and will
      be directed to open and break the codes only at the event of adverse events after discussion
      with sponsor and the monitor.

      Patients will be informed that they may withdraw from the study at any time for any reasons.
      The Investigator also has the right to withdraw patients from the study if it is in the best
      interest of the patient. The reason and date of discontinuation will to be clearly documented
      in the case report form for all patients who discontinued the study product prematurely.

      Periodontal examination periodontal probe depth (PPD), clinical attachment level (CAL),
      bleeding on probing index (BOP),plaque index (PI), and tooth mobility, will be conducted at
      the screening period and scheduled study visits. Photographs of the dental cavity were taken
      at the start and end of the study treatment.

      Radiographs were compared at the beginning and end of the study to compare the bone level and
      record other relevant findings.

      At baseline each volunteer will be received a Full Mouth Disinfection (FMD) and, to ensure
      that all deposits has been removed, a disclosing episode will be carried out after which any
      remaining plaque will be removed.

      Saliva samples (at least 3 mL) will be collected in eppendorf tubes and immediately frozen at
      -20°C.

      The activity of Arginine deiminase will be evaluated by High Performance Liquid
      Chromatography of fluorescence derivatized aminoacids, by monitoring the formation of
      citrulline from Arginine.

      For metabonomic analysis the saliva samples will be collected in the morning in a sterile
      tube containing sodium fluoride as an antimicrobic agent. Patients must refrain from eating,
      drinking, smoking or dental washing before the collection.

      The samples will be kept on ice and will be stored at -80°C as soon as possible.

      Plaque samples will be collected with a sterile curette and dispersed in sterilized saline
      solution and stored at -20°C.

      Microbiota will be analyzed on DNA extracted from the samples using a Qiagen kit. L.brevis
      CD2 strain will be detected using a TaqMan Real Time PCR, by using specifically designed
      primers. Microbial flora potentially involved in periodontitis, will be identified and
      quantified by molecular biology techniques.

      Breath samples will be collected in 1 mL disposable syringe (latex-free) and immediately
      analyzed between a portable gas chromatograph device (Oral Chroma, Abimedical corporation,
      Osaka, Japan).

      Blood samples (20-25mL) will be collected by only 20% of population on the study al baseline
      and at end of the treatment period (6 weeks).
    

Intervention name(s): lactobacillus brevis tablets; PLACEBO
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5 tablets a day for 6 weeks; 5 tablets a day for 6 weeks
Other intervention name(s): Inersan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Chronic Peridodontitis; probiotics; lactobacillus brevis; full mouth disinfection