Mild and Moderate Chronic Periodontitis
Conditions
Brief summary
The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.
Interventions
DRUGProbiotic Arm
Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2
DRUGPlacebo Arm
Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)
Sponsors
Government Dental College and Hospital, Vijayawada, Andra Pradesh, India
CD Pharma India Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic mild to moderate periodontitis. * Having Pocket depth \> 4mm. * Mean loss of attachment, evaluated by measuring the distance from cement-enamel junction to the bottom of the probing pocket \> 4mm
Exclusion criteria
* Patients on probiotic supplements * Patients who have allergy to lactose and fermented milk products * Smokers * Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months * Patients with advanced periodontal and/or periapical conditions which necessitate immediate treatment * Patient suffering from any systemic illness * Patients who are deemed to be un-cooperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Clinical Periodontal Indices | 8 weeks | Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Biochemical Indices | 8 weeks | Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF) |
Countries
India
Outcome results
None listed