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Completed

NCT Number: NCT02390687

Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients

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 .

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Key information

Age range

35 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Periodontics, K.V.G. College & Hospital,

Kurunjibhag, Sullia (d.k.), Karnataka, 574327, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Drug

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

Other names: L. brevis CD2 Lozenges

Placebo

Drug

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

Primary outcomes

  1. Improvement in Periodontal Clinical indices

    Time frame: 8 weeks

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

Secondary outcomes

  1. Change in bone pattern

    Time frame: 8 weeks

    Assessment of changes in bone patterns in bith group using digital radio-graphic technique

Sponsors and collaborators

Lead sponsor

Next Gen Pharma India Pvt. Ltd.

Industry

Collaborators

  • KVG Medical College and Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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