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Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients

Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02390687
Enrollment
31
Registered
2015-03-17
Start date
2015-04-30
Completion date
2016-12-31
Last updated
2017-01-10

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

Conditions

Chronic Periodontitis

Brief summary

Periodontitis is an infectious inflammatory disease. Bacteria modulate the inflammatory response and alter the diversity of periodontal disease. In recent years, various host-response modulation therapies have been developed to block the pathways responsible for periodontal tissue breakdown. There have been significant changes with respect to the effectiveness of, and attitudes towards conventional antimicrobial therapy to combat disease. With the threat of widespread antibiotic resistance rendering many antibiotics useless against important diseases, there is an increased necessity not only to minimise antibiotic use and develop novel non-antibiotic-based treatments, but also to raise the profile of disease prevention. One approach that has gained interest over recent years is the use of probiotic bacteria for oral applications. The rationale for their use in oral health care stems from the increase in evidence that supports their claims for benefit for a range of diseases. Lactobacilli play an important role in the maintenance of health by stimulating the natural immunity as well as by contributing to the balance of the microflora, by interacting with the other members of the flora. The application of health promoting bacteria for therapeutic purposes, is one of the strongest emerging fields. Time has come to shift the paradigm of the treatment from specific bacteria elimination to alteration of the bacterial ecology by using probiotics. So the purpose of this study is to discover a more promising approach for the treatment of chronic periodontitis .

Interventions

DRUGProbiotic

Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2

DRUGPlacebo

Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Sponsors

KVG Medical College and Hospital
CollaboratorOTHER
Next Gen Pharma India Pvt. Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 49 Years
Healthy volunteers
No

Inclusion criteria

* Clinically diagnosed chronic generalized periodontitis * Need of phase 1 therapy * Pocket probing depth (PPD) of ≥ 5 mm \< 7 mm at two and/or more sites * Patients with no history of allergies to the drugs to be used

Exclusion criteria

* Patients on antibiotics within 3 month prior to study * Patients with any systemic diseases * Patients with history of any periodontal therapy within 6 months to trial

Design outcomes

Primary

MeasureTime frameDescription
Improvement in Periodontal Clinical indices8 weeksImprovement in periodontal clinical indices, namely, Gingival Index (GI), Bleeding on probing (BOP), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).

Secondary

MeasureTime frameDescription
Change in bone pattern8 weeksAssessment of changes in bone patterns in bith group using digital radio-graphic technique

Countries

India

Outcome results

None listed

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