Efficacy of Oral Probiotic and Antibiotic Administration in Patients With Chronic Periodontitis

University of Chile

Status and phase: Unknown; Phase 2

Conditions: Chronic Periodontitis

Treatments: Other: Talc powder; Procedure: Periodontal treatment Scaling and root planning; Dietary Supplement: Lactobacillus rhamnosus SP1; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02839408

FONDECYT 1130570.b

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups, including a placebo group

Periodontal treatment, talc powder tab

Placebo Comparator group

Description:

Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months

Treatment:

Procedure: Periodontal treatment Scaling and root planning

Other: Talc powder

Periodontal treatment, Probitic

Experimental group

Description:

Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.

Treatment:

Procedure: Periodontal treatment Scaling and root planning

Dietary Supplement: Lactobacillus rhamnosus SP1

Periodontal treatment, Antibiotic

Experimental group

Description:

Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin

Treatment:

Procedure: Periodontal treatment Scaling and root planning

Drug: Azithromycin