Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients

NCT02390687 | Completed Phase 3

• 1 other identifier: SUL_PERIO-RG_01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in bone pattern

  8 weeks

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Placebo Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Drug: Placebo

Probiotic Arm

EXPERIMENTAL

L. brevis CD2 Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2

Drug: Probiotic

Interventions

Probiotic DRUG

Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2

Also known as: L. brevis CD2 Lozenges

Probiotic Arm

Placebo DRUG

Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Placebo Arm

Eligibility Criteria

• Age: 35 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Next Gen Pharma India Pvt. Ltd.: lead
• KVG Medical College and Hospital: collaborator

Study Sites (1)

Department of Periodontics, K.V.G. College & Hospital,

Kurunjibhag, Sullia (d.k.), Karnataka, 574327, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mudnoor M Dayakar, MDS

  KVG Medical College & Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 17, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

IN (1)