Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis

A Comparative Evaluation of the Effect of Probiotic Inersan and Doxycycline on Chronic Periodontitis - A Clinical and Microbiological Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02174757

Enrollment

Registered

2014-06-26

Start date

2014-08-31

Completion date

2014-11-30

Last updated

2014-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Brief summary

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.

Interventions

DRUGInersan

Probiotic

DRUGDoxycycline

Antibiotic

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Improvement in periodontal clinical indices	4 weeks	Improvement in periodontal clinical indices, namely, Gingival Index (GI), Probing Pocket Depth (PPD), Plaque Index (PI) and Clinical Attachment level (CAL)

Secondary

Measure	Time frame	Description
Improvement in microbiological indices	4 weeks	Changes in salivary count of Lactobacilli and Porphyromonas gingivalis

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026