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IRCT20130216012487N7 IRCT 2020-11-22 Esfahan University of Medical Sciences Clinical and bacteriological Effects of Synbiotic as an Adjunct in Phase I Periodontal Therapy Analysis of the clinical and bacteriological effects scailing and root planing with assumption of synbiotic product or placebo as the complementary treatment in patients with chronic periodontitis 2017-11-06 anticipated 28 Complete https://irct.ir/trial/45250 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients were randomly selected via throwing the coin to treat by one of the treatment, Blinding description: All the variables were measured and microbial sampling was carried out by another examiner who was blind to the selected treatment modalities for each tooth. 3 Chronic periodontitis. Intervention 1: Intervention group: Dissolve 1 sachet synbiotic Product in 30ml water and use it as mouthwash twice a day after tooth brushing. Intervention 2: Control group: Dissolve 1 sachet of placebo in 30ml water and use it as mouthwash twice a day after tooth brushing. Yes - There is a plan to make this available What will be shared: The documentation for this study is available to other researchers. Available documents will include data related to all studied variables (except patients' personal information) and in the form of SPSS‌ file. When: 3 months after printing the results To whom: The information of this research can be shared with all academic researchers. Conditions: For research and clinical use Where to obtain: Ways of communication with the responsible researcher: Email: sh.amini@khuisf.ac.ir How to obtain: After coordination with the responsible researcher, the requested data will be sent within one month. Comments:

public Shirin amini

Dental School, Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan

Isfahan Iran (Islamic Republic of) 8155139998 +98 31 1535 4053 Sh.amini@khuisf.ac.ir Dental School, Isfahan Branch, Islamic Azad University scientific Amini, Shirin

Dental School, Isfahan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan,

Isfahan Iran (Islamic Republic of) 8155139998 +98 31 1535 4053 Sh.amini@khuisf.ac.ir Dental School, Isfahan Branch, Islamic Azad University Iran (Islamic Republic of) Patient with complete physical and mental health Who were not treated for periodontitis during the last two years Who did not use probiotic food products during the past year Who have at least 10 to 12 areas with the pocket depth of 3mm to 6 mm with bleeding on probing. no limit no limit Both subjects with history of uncontrolled diabetes, AIDS, rheumatic fever, severe hepatic and renal problems, deficiency in immunological and neurological systems patients consuming any type of medicine that affect periodontal tissue (Phenytoin, Cyclosporine and Nifedipine) pregnant and lactating women smokers and alcoholic subjects subjects with a pocket depth of more than 6 mm K05.3 Chronic periodontitis Treatment - Drugs Placebo Intervention group: Dissolve 1 sachet synbiotic Product in 30ml water and use it as mouthwash twice a day after tooth brushing Control group: Dissolve 1 sachet of placebo in 30ml water and use it as mouthwash twice a day after tooth brushing Count of Porphyromonas gingivalis in subgingival plaque. Timepoint: At baseline and 30 days after intervention. Method of measurement: Dilution and culture of bactery samples in riched solid blood agar and black pigmentation of Porphyromonas gingivalis visual colony counting and microscopic experiments for detection of the gram negative bacillus of Porphyromonas gingivalis and biochemical tests. Measuring pocket depth. Timepoint: At baseline and 30 days after intervention. Method of measurement: Measuring of pocket depth in mm by a University of Michigan probe with Wiliams markings. Measuring clinical attachment loss. Timepoint: At baseline and 30 days after intervention. Method of measurement: Measuring of clinical attachment loss in mm by University of Michigan with Wiliams markings probe. Evaluation of bleeding on probing. Timepoint: At baseline and 30 days after intervention. Method of measurement: Probing by University of Michigan with Wiliams markings probe and then clinical absevation. Esfahan University of Medical Sciences Approved 2017-09-24 Ethics Committee of Isfahan Branch, Islamic Azad University Isfahan Branch, Islamic Azad University, University Boulevard, Arghavaniyeh street, Eastern Jey Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)