NCT02203812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

1.1 years

First QC Date

July 28, 2014

Last Update Submit

July 26, 2016

Conditions

Mild and Moderate Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Improvement in Clinical Periodontal Indices

    Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP)

    8 weeks

Secondary Outcomes (1)

  • Improvement in Biochemical Indices

    8 weeks

Study Arms (2)

Probiotic Arm

EXPERIMENTAL

L. brevis CD2 Lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). Each lozenge contains at least 1 billion colony forming units of Lactobacillus brevis CD2.

Drug: Probiotic Arm

Placebo Arm

PLACEBO COMPARATOR

Placebo lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). The placebo lozenge contains all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2).

Drug: Placebo Arm

Interventions

Probiotic ArmDRUG

Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2

Probiotic Arm
Placebo ArmDRUG

Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)

Placebo Arm

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology, Government Dental College & Hospital

Vijayawada, Andhra Pradesh, 520004, India

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Surya Jyotsna Kiran Kanchumurthy, BDS

    Government Dental College and Hospital, Vijayawada, Andhra Pradesh

    PRINCIPAL INVESTIGATOR

  • Narendra Dev Jampani, MDS

    Government Dental College and Hospital, Vijayawada, Andhra Pradesh

    STUDY DIRECTOR

  • Vajra Madhuri S, MDS

    Government Dental College and Hospital, Vijayawada, Andhra Pradesh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 30, 2014

Study Start

January 1, 2015

Primary Completion

February 1, 2016

Study Completion

May 1, 2016

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

IN(1)