Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis

NCT02283736 — Phase 2, Unknown, 36 participants, Jorge Gamonal

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

Registry	NCT02283736, acronym probiotic
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	36 (Actual)
Sponsor	Jorge Gamonal (Other)
Conditions	-Chronic Periodontitis
Interventions	Lactobacillus rhamnosus SP1, Talc powder, Periodontal treatment (Other, procedure)
Dates	start 2014-06-01, primary completion 2015-06-01, completion 2016-12-01 (estimated), first posted 2014-11-05, last updated 2016-06-15
Locations	1 site in Chile

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Periodontal treatment, Probitic	Experimental	Other: Lactobacillus rhamnosus SP1; Procedure: Periodontal treatment	Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months.
Periodontal treatment, talc powder tab	Placebo comparator	Other: Talc powder; Procedure: Periodontal treatment	Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months

Lactobacillus rhamnosus SP1 (Other): Tablet containing Lactobacillus rhamnosus SP1
Talc powder (Other): Tablet containing talc powder
Periodontal treatment (Procedure): Scaling and root planning

+Outcome measures

Primary outcomes

Differences of at least 1mm between groups for clinical attachment level changes [baseline, 3, 6 months]

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 35 Years to any

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

+Locations (1)

Facility	City	Country	Status
Faculty of Dentistry of University of Chile	Santiago, Santiago Metropolitan	Chile

+Investigators

Jorge Gamonal, Professor, Principal investigator, Faculty of Dentistry of University of Chile