EVALUATION OF THE EFFICACY OF ORALY ADMINISTERED PROBIOTIC BACILLUS COAGULANS AND STREPTOCOCCUS SALIVARIUS AS AN ADJUVANT TO SCALING AND ROOT PLANING IN PERIODONTITIS PATIENTS: A RANDOMIZED CLINICAL STUDY

Patients will berecruited for the study based on the Inclusion and Exclusion criteria.

•Patients willreceive information about the etiology of periodontal disease and need forprobiotic therapy and informed written consent will be taken.

•Patients will berecalled for saliva sample collection for assessment of IL-6 and plaque samplecollection for assessment of Porphyromonas gingivalis, Bacillus coagulans& Streptococcus salivarius and phase I therapy.

TREATMENT PROTOCOL

•Followingcollection of saliva sample and subgingival plaque sample, clinical parameterslike plaque index, gingival index, probing pocket depth and clinical attachmentlevel will be measured and recorded in a proforma.

•After recordingof baseline parameters, patients will be randomly allocated to test and controlgroup using a randomization table.

•To maintain fullblinding of results the randomization code will be held by the guide remotelyfrom all assessments and will not be broken until all data has been collectedand all analysis has been performed.

•The randomizationwill be concealed by using sequentially numbered identical appearing containersof probiotics and placebo group

•All the patientswill receive single visit full mouth debridement using ultrasonic scaler andGracey curettes.

•Instructions formaintaining adequate plaque control and oral hygiene instructions will begiven. Also, the patients will be instructed not to use any other mechanical orchemical plaque agent during the study period.

•Then the patientswill be supplied with Bacillus coagulans probiotic,  Streptococcus salivarius probiotic and placebo tablets to be taken once daily 1 hour afterdinner for 1 month.

•Patients will beinstructed to chew the tablet for 1 minute, swish it around the mouth and thenswallow.

•Clinicalparameters will be recorded again at 1 month and 3 months recall visits.

•The assessment ofclinical parameter at baseline, 1month, and 3months will be carried out by anindependent examiner who is blinded about the treatment groups.

IMMUNOLOGICALASSESSMENT:

•Salivary IL-6will be estimated using commercially available ELISA kit.

•5ml ofunstimulated saliva samples will be collected from each patient. Saliva will becollected between 9-11 am in all the patients to avoid diurnal variation priorto subgingival plaque collection and clinical parameter recording to avoidcontamination of the samples with blood.

•All patients willbe asked to avoid food consumption for at least 1 hour before salivacollection. Patient will be seated on a dental chair and saliva will becollected over 5 min period with instructions to pool saliva in the floor ofthe mouth and passively drool it into a sterile container.

•Collected samplewill be centrifuged at 5000 rpm for 10 minutes.

•Supernatant willbe immediately transferred to a sterile plastic vial and stored at -80°C andlater will be send to laboratory for further processing.

MICROBIOLOGICALASSESSMENT:

•A site withdeepest probing pocket depth will be selected for microbial sampling from everyparticipant at baseline, 1month and 3months.

•Subgingivalplaque samples will be collected using sterilized curette and then suspended in1ml normal saline solution and will be subjected to evaluation using Real TimePolymerase chain reaction for P gingivalis, B. coagulans & Streptococcussalivarius