NCT02174757

Brief Summary

Periodontitis is a multifactorial disease that can lead to the destruction of supporting tissues of the teeth resulting in pocket formation, recession or both. Since the primary etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm, efforts for disease prevention and treatment are mainly focused on pathogen reduction and strengthening of epithelial barrier, thus contributing to decreased susceptibility to infection. Due to emergence of antibiotic resistance and frequent recolonization of treated sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced to periodontal disease. The need was fulfilled by the introduction of Probiotics and Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning "for life" are microorganisms proven to exert health promoting influences in humans and animals. Food and Agriculture Organization and WHO have stated that there is potential for probiotic foods to provide health benefits and that specific strains are safe for human use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2014

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

June 19, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 15, 2014

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

June 19, 2014

Last Update Submit

December 12, 2014

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Improvement in periodontal clinical indices

    Improvement in periodontal clinical indices, namely, Gingival Index (GI), Probing Pocket Depth (PPD), Plaque Index (PI) and Clinical Attachment level (CAL)

    4 weeks

Secondary Outcomes (1)

  • Improvement in microbiological indices

    4 weeks

Study Arms (3)

Inersan

EXPERIMENTAL

Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2.

Drug: Inersan

Inersan and Doxycycline together

EXPERIMENTAL

Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline. Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2.

Drug: InersanDrug: Doxycycline

Doxycycline

ACTIVE COMPARATOR

Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.

Drug: Doxycycline

Interventions

InersanDRUG

Probiotic

Also known as: Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2
InersanInersan and Doxycycline together
DoxycyclineDRUG

Antibiotic

Also known as: Each tablet contains 100 mg of Doxycycline
DoxycyclineInersan and Doxycycline together

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects in both sexes
  • Age 25 - 60 yrs
  • Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in \> 30 % of the probing sites
  • Subjects in good general health

You may not qualify if:

  • Antibiotic therapy in the past 2 months
  • Allergic to doxycycline or probiotics
  • Subjects with diabetic mellitus, hypertension and psychiatric disorders
  • Subjects who are pregnant/ lactating
  • Smokers and/or alcoholics
  • Subjects who have undergone any periodontal therapy within last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Periodontics and Implantology, Sree Mookambika Institute of Dental Sciences

Kulasegaram, Tamil Naidu, 629161, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Arya K.S., BDS

    Sree Mookambika Institute of Dental Sciences

    PRINCIPAL INVESTIGATOR

  • Elizabeth Koshi, MDS

    Sree Mookambika Institute of Dental Sciences

    STUDY DIRECTOR

  • Arun Sadasivan, MDS

    Sree Mookambika Institute of Dental Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 26, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 15, 2014

Record last verified: 2014-12

Locations

IN(1)