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OpenTrials
Completed

NCT Number: NCT02121665

Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.

Periodontal disease is an infectious disease resulting in inflammation within supporting tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies reveal that about 10% of the adult population suffer from severe periodontitis.It comprises of two distinct but interconnected etiologic components: the periodontopathic bacteria adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. In the arena of periodontics, the probiotics pose a great potential of plaque modification, halitosis management, altering anaerobic bacteria colonization, improvement of pocket depth, and clinical attachment gain.

Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to Scaling and Root Planing, on clinical and biochemical parameters.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Periodontics, Government Dental College & Hospital

Aurangabad, Maharashtra, 415570, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject of both sexes
  • Age group of 25-65 years
  • Subjects with generalized moderate to severe chronic periodontitis
  • Signed informed Consent

Exclusion criteria

  • Any known history of systemic diseases
  • Patients already on anti-inflammatory drugs or antibiotics
  • Patients allergic to any material used in the study
  • Pregnant and lactating women
  • Periodontal therapy in past 6 months
  • Current smoker or smoker in the past

Treatment and study plan

Probiotic (Inersan)

Drug

Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2

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: 6 weeks

    Improvement in periodontal clinical indices, namely, Gingival Index (GI), Plaque Index (PI), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).

Secondary outcomes

  1. Improvement in biochemical indices

    Time frame: 6 weeks

    Changes in level of inflammatory markers namely PGE2, IL-1beta, TNF-alpha, receptor activator of nuclear factor kappa B ligand (RANKL), Osteoprotegerin (OPG), MMP-9 and MMP-13 in saliva sample

Sponsors and collaborators

Lead sponsor

CD Pharma India Pvt. Ltd.

Industry

Collaborators

  • Government Dental College and Hospital, India

Registry information

Official study title

Effect of Probiotic Lozenges as an Adjunct to Non Surgical Periodontal Therapy in Chronic Periodontitis Patients: A Randomized Double Blind Placebo Controlled Clinical and Biochemical Study.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 23, 2014
Registry last updated
Jul 27, 2016

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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