Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis

CD Pharma

Status and phase: Completed; Phase 3

Conditions: Chronic Periodontitis

Treatments: Drug: Inersan; Drug: Doxycycline

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02174757

KUL_SMIDS_PERIO_01

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Inersan

Experimental group

Description:

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.

Treatment:

Drug: Inersan

Inersan and Doxycycline together

Experimental group

Description:

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.

Treatment:

Drug: Doxycycline

Drug: Inersan

Doxycycline

Active Comparator group

Description:

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

Treatment:

Drug: Doxycycline