Chronic Periodontitis
Conditions
Keywords
periodontitis, azithromycin, probiotic
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus rhamnosus SP1
Sachet containing Lactobacillus rhamnosus SP1
DRUGAzithromycin
Tablet containing 500mg Azithromicyn
OTHERTalc powder
Sachet containing talc powder and tablet containing talc powder
PROCEDUREPeriodontal treatment Scaling and root planning
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 14 natural teeth, excluding third molars * 10 posterior teeth * 35 years old * 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm Bleeding on probing ≥20% of sites Extensive bone loss determined radiographically
Exclusion criteria
* Periodontal treatment before the time of examination * Systemic illness * Pregnancy Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences of at least 1mm between groups for clinical attachment level changes | baseline, 3, 6, 9 and 12 month |
Secondary
| Measure | Time frame |
|---|---|
| Differences between groups for bleeding on probing changes | baseline, 3, 6, 9 and 12 month |
| Differences between groups for plaque index changes | baseline, 3, 6, 9 and 12 month |
| Differences between groups for probing depth changes | 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 | baseline, 3, 6, 9 and 12 month |
| Differences between groups for levels of periodontal pathogens changes | baseline, 3, 6, 9 and 12 month |
Countries
Chile
Outcome results
None listed