Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients
This trial has been completed.
|Sponsor||Next Gen Pharma India Pvt. Ltd.|
|Collaborator||K. V. G. DENTAL COLLEGE & HOSPITAL|
|Start date||April 2015|
|End date||September 2016|
|Trial size||31 participants|
|Trial identifier||NCT02390687, SUL_PERIO-RG_01|
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 .
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Improvement in Periodontal Clinical indices
time frame: 8 weeks
Change in bone pattern
time frame: 8 weeks
Male or female participants from 35 years up to 49 years old.
- 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
- 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
|Official title||Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.|
|Principal investigator||Mudnoor M Dayakar, MDS|
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