CLINICAL, MICROBIOLOGICAL AND IMMUNOLOGICAL 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
Not Applicable
Not yet recruiting
- Conditions
- Health Condition 1: K053- Chronic periodontitis
- Registration Number
- CTRI/2022/08/044650
- Lead Sponsor
- nique Biotech Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a. Age between 30-65years.
b. Patients with stage II and stage III periodontitis according to AAP 2017 classification will be included.10
c)30% or more of sites with probing pocket depth (PPD>= 4mm and CAL>=4mm
d)A minimum of five teeth with at least one site with CAL and PPD>=4mm.
Exclusion Criteria
a. Antimicrobial therapy in the previous three months
b. Presence of systemic conditions
c. History of smoking
d. Need of prophylactic antibiotic therapy for routine dental procedures.
e. long term administration of anti-inflammatory medications.
f. Usage of probiotics in the past six months before the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Probing pocket depth assessed at six sites per tooth. <br/ ><br>Microbiological counts of Porphyromonas gingivalis <br/ ><br>Microbiological counts of Bacillus coagulans <br/ ><br>and Streptococcus salivarius <br/ ><br>Levels of IL6.Timepoint: BASELINE, 1 MONTH AND 3 MONTHS FOLLOWING PROBIOTIC AND PLACEBO INTERVENTIO
- Secondary Outcome Measures
Name Time Method Clinical Attachment Level CAL assessed at six sites per tooth. <br/ ><br>Plaque Index Silness and Loe 1964 <br/ ><br>Gingival Index Loe and Silness 1963 <br/ ><br>Timepoint: BASELINE, 1 MONTH AND 3 MONTHS FOLLOWING PROBIOTIC AND PLACEBO INTERVENTIO