Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients

Chronic Periodontitis Clinical Trial

Official title:

Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390687
• Other study ID #: SUL_PERIO-RG_01
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2015
• Last updated: January 9, 2017
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Next Gen Pharma India Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Probiotic
Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2
• Placebo
Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Locations

Country	Name	City	State
India	Department of Periodontics, K.V.G. College & Hospital,	Kurunjibhag, Sullia (D.K.)	Karnataka

Sponsors (2)

Lead Sponsor	Collaborator
Next Gen Pharma India Pvt. Ltd.	K. V. G. DENTAL COLLEGE & HOSPITAL

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Periodontal Clinical indices	Improvement in periodontal clinical indices, namely, Gingival Index (GI), Bleeding on probing (BOP), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).	8 weeks	No
Secondary	Change in bone pattern	Assessment of changes in bone patterns in bith group using digital radio-graphic technique	8 weeks	No