Effect of a Locally Delivered Probiotic in Periodontitis

NCT ID: NCT02645669

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-08-31

Brief Summary

Saccharomyces boulardii is commonly employed as a live non-pathogenic probiotic microbial feed or food supplement. S. boulardii reduces the secretion of key pro inflammatory cytokines and promotes the production of anti-inflammatory cytokines such as IL-10, which is pertinent in the context of pathogenic mechanisms in periodontitis.

Detailed Description

One method of altering the subgingival environment is by using probiotics. Probiotics are live microorganisms, which when administered in adequate amounts, confer a health benefit on the host by passively occupying a niche that may otherwise be colonized by pathogens. This tends to limit a pathogen's ability to bind to tissue surfaces and to produce virulence factors.8 In the past few years, probiotics have been investigated for periodontal health. Studies have shown that certain gut bacteria can exert beneficial effects in the oral cavity by inhibiting pathogenic species. Teughels et al., in a study showed that application of beneficial oral bacteria subgingivally after scaling and root planing led to a more host compatible subgingival microbiota which may also effect the promotion of a beneficial host response.10 Studies have revealed that probiotic Lactobacillus strains (L. reuteri, L salivarius, L. casei, L. acidophilus) were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis, in the saliva and subgingival plaque. Streptococcus sanguinis & S. uberis were found to inhibit the growth of periodontopathogens & a strong negative between Aggregatibacter actinomycetemcomitans and S. sanguinis. Weissella cibaria isolates in the form of probiotic rinse possess the ability to inhibit biofilm formation, both in vitro and in vivo.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study site

Scaling and Root planing (SRP) was followed by placement of S boulardii-FOS mixture

Group Type: EXPERIMENTAL

Study site

Intervention Type: PROCEDURE

The probiotic is in the form of a lyophilized powder containing approximately 5 billion colony forming units (CFU) of the Saccharomyces boulardii. At the time of administration, the probiotic mixture was mixed with fructooligosaccharide in the ratio of 4:1 to induce growth and activity in S boulardii. This was applied after scaling and root planing.

Control site

Only Scaling and Root planing (SRP) was performed

Group Type: PLACEBO_COMPARATOR

Control site

Intervention Type: PROCEDURE

Only Scaling and Root planing was done.

Interventions

Study site

The probiotic is in the form of a lyophilized powder containing approximately 5 billion colony forming units (CFU) of the Saccharomyces boulardii. At the time of administration, the probiotic mixture was mixed with fructooligosaccharide in the ratio of 4:1 to induce growth and activity in S boulardii. This was applied after scaling and root planing.

Intervention Type: PROCEDURE

Control site

Only Scaling and Root planing was done.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subjects having at least one pocket ≥5 mm in each quadrant were included in the study.

Exclusion Criteria

• Medically compromised patients and patients having received any form of surgical or non-surgical therapy in the 6 month period leading to the study were not included.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SVS Institute of Dental Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr R Viswa Chandra

Professor and Head, Periodontics, SVSIDS, Mahabubnagar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rampalli V Chandra, MDS;DNB

Role: PRINCIPAL_INVESTIGATOR

IEC, SVSIDS, Mahabubnagar

Locations

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, India

Countries

India

Other Identifiers

D139406038

Identifier Type: OTHER

Identifier Source: secondary_id

SVSIDS/PERIO/2/2014

Identifier Type: -

Identifier Source: org_study_id