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Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis

NCT ID: NCT02174757

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-11-30

Brief Summary

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Periodontitis is a multifactorial disease that can lead to the destruction of supporting tissues of the teeth resulting in pocket formation, recession or both. Since the primary etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm, efforts for disease prevention and treatment are mainly focused on pathogen reduction and strengthening of epithelial barrier, thus contributing to decreased susceptibility to infection. Due to emergence of antibiotic resistance and frequent recolonization of treated sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced to periodontal disease. The need was fulfilled by the introduction of Probiotics and Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning "for life" are microorganisms proven to exert health promoting influences in humans and animals. Food and Agriculture Organization and WHO have stated that there is potential for probiotic foods to provide health benefits and that specific strains are safe for human use.

Detailed Description

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Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inersan

Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2.

Group Type EXPERIMENTAL

Inersan

Intervention Type DRUG

Probiotic

Inersan and Doxycycline together

Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.

Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2.

Group Type EXPERIMENTAL

Inersan

Intervention Type DRUG

Probiotic

Doxycycline

Intervention Type DRUG

Antibiotic

Doxycycline

Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

Antibiotic

Interventions

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Inersan

Probiotic

Intervention Type DRUG

Doxycycline

Antibiotic

Intervention Type DRUG

Other Intervention Names

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Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2 Each tablet contains 100 mg of Doxycycline

Eligibility Criteria

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Inclusion Criteria

1. Subjects in both sexes
2. Age 25 - 60 yrs
3. Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in \> 30 % of the probing sites
4. Subjects in good general health

Exclusion Criteria

1. Antibiotic therapy in the past 2 months
2. Allergic to doxycycline or probiotics
3. Subjects with diabetic mellitus, hypertension and psychiatric disorders
4. Subjects who are pregnant/ lactating
5. Smokers and/or alcoholics
6. Subjects who have undergone any periodontal therapy within last 6 months.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sree Mookambika Institute of Dental Sciences

UNKNOWN

Sponsor Role collaborator

CD Pharma India Pvt. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arya K.S., BDS

Role: PRINCIPAL_INVESTIGATOR

Sree Mookambika Institute of Dental Sciences

Elizabeth Koshi, MDS

Role: STUDY_DIRECTOR

Sree Mookambika Institute of Dental Sciences

Arun Sadasivan, MDS

Role: PRINCIPAL_INVESTIGATOR

Sree Mookambika Institute of Dental Sciences

Locations

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Dept. of Periodontics and Implantology, Sree Mookambika Institute of Dental Sciences

Kulasegaram, Tamil Naidu, India

Site Status

Countries

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India

Other Identifiers

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KUL_SMIDS_PERIO_01

Identifier Type: -

Identifier Source: org_study_id