Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis (probiotic)

Jorge Gamonal

Status and phase: Unknown; Phase 2

Conditions: -Chronic Periodontitis

Treatments: Other: Talc powder; Other: Lactobacillus rhamnosus SP1; Procedure: Periodontal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02283736

FONDECYT 1130570

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 as an adjunct to scaling and root planning (SRP).

Material and methods: Thirty six chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The tablets will be used once per day during 3 months.

Enrollment: 36 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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36 participants in 2 patient groups, including a placebo group

Periodontal treatment, Probitic

Experimental group

Description:

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

Treatment:

Other: Lactobacillus rhamnosus SP1

Procedure: Periodontal treatment

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:

Other: Talc powder

Procedure: Periodontal treatment