Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis

Efficacy of Oral Probiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02283736

Acronym

probiotic

Enrollment

Registered

2014-11-05

Start date

2014-06-30

Completion date

2016-12-31

Last updated

2016-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

-Chronic Periodontitis

Keywords

Chronic periodontitis, Probiotics, Non- surgical treatment

Brief summary

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.

Interventions

OTHERLactobacillus rhamnosus SP1

Tablet containing Lactobacillus rhamnosus SP1

OTHERTalc powder

Tablet containing talc powder

PROCEDUREPeriodontal treatment

Scaling and root planning

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

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 months

Secondary

Measure	Time frame
Differences between groups for probing depth changes	baseline, 3, 6 month
Differences between groups for bleeding on probing changes	baseline, 3, 6 months
Differences between groups for plaque index changes	baseline, 3, 6 months
Differences between groups for levels of Interleukin (IL)-17, IL-21, Transforming Growth Factor (TGF)- beta, IL-10, RANKL changes in gingival crevicular fluid	baseline, 3, 6 months
Differences between groups for levels of periodontal pathogens changes	baseline, 3, 6 months

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026