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Trial record 44 of 312 for:    "Periodontitis, Chronic"

Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients

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ClinicalTrials.gov Identifier: NCT02390687
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
KVG Medical College and Hospital
Information provided by (Responsible Party):
Next Gen Pharma India Pvt. Ltd.

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 .


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Probiotic Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.
Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Placebo Comparator: Placebo Arm
Placebo Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
Drug: Placebo
Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Experimental: Probiotic Arm
L. brevis CD2 Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2
Drug: Probiotic
Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2
Other Name: L. brevis CD2 Lozenges




Primary Outcome Measures :
  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 Outcome Measures :
  1. Change in bone pattern [ Time Frame: 8 weeks ]
    Assessment of changes in bone patterns in bith group using digital radio-graphic technique



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Ages Eligible for Study:   35 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390687


Locations
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India
Department of Periodontics, K.V.G. College & Hospital,
Kurunjibhag, Sullia (D.K.), Karnataka, India, 574327
Sponsors and Collaborators
Next Gen Pharma India Pvt. Ltd.
KVG Medical College and Hospital
Investigators
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Principal Investigator: Mudnoor M Dayakar, MDS KVG Medical College & Hospital

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Responsible Party: Next Gen Pharma India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02390687     History of Changes
Other Study ID Numbers: SUL_PERIO-RG_01
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases