NCT02329353

Brief Summary

Periodontitis is one of the most common chronic inflammatory disease with the etiology of bacterial plaque and is associated with a number of putative bacterial species. The periodontal destruction is substantially mediated by the host, driven by the bacterial challenge. The presence of pathogenic bacteria with the absence of so-called "beneficial bacteria" and the susceptibility of the host are the main aetiological factors of periodontal diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2015

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

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

December 29, 2014

Last Update Submit

January 9, 2017

Conditions

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)

    8 weeks

Secondary Outcomes (1)

  • Change in microbiological indices

    8 weeks

Study Arms (2)

Smoker group

EXPERIMENTAL

30 chronic periodontitis patients, having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks

Drug: Lactobacillus brevis CD2 Lozenges

Non-smoker

EXPERIMENTAL

30 chronic periodontitis patients, not having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks

Drug: Lactobacillus brevis CD2 Lozenges

Interventions

Lactobacillus brevis CD2 LozengesDRUG

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

Also known as: Probiotics
Non-smokerSmoker group

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients free from any systemic illness
  • Previously untreated moderate to severe generalised chronic periodontitis.
  • Patients free from adverse reactions to lactose or fermented milk products
  • Patient unwilling to quit smoking and smokers over the past one year ( Smoker arm).

You may not qualify if:

  • Previous history of antibiotic usage over past 6 months
  • Patients who are eligible for antibiotic usage during the treatment course
  • Patients who are pregnant, lactating, alcoholic or who had undergone any surgical or nonsurgical therapy within 6 months.
  • Acute oral lesions or necrotising ulcerative periodontitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krishnadevaraya College of Dental Sciences and Hospital

Bangalore, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Rudrakshi chickanna, MDS

    KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE

    PRINCIPAL INVESTIGATOR

  • Shruthi J R, BDS

    KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE

    PRINCIPAL INVESTIGATOR

  • Prabhuji MLV, MDS

    KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2014

First Posted

December 31, 2014

Study Start

February 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

IN(1)