The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an adjunct to scaling and root planning (SRP). Material and methods: Fifty-four chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used once per day during 3 months. Antibiotic will be used once per day during 5 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Sachet containing Lactobacillus rhamnosus SP1
Tablet containing 500mg Azithromicyn
Sachet containing talc powder and tablet containing talc powder
Faculty of Dentistry of University of Chile
Santiago, Santiago Metropolitan, Chile
Differences of at least 1mm between groups for clinical attachment level changes
Time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for probing depth changes
Time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for bleeding on probing changes
Time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for plaque index changes
Time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid
Time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for levels of periodontal pathogens changes
Time frame: baseline, 3, 6, 9 and 12 month
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