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Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients

NCT02357771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-09-23

No results posted yet for this study

Summary

Advances in orthodontics have improved the quality of appliances and treatment protocols, raising the standard of patient care. However, enamel demineralization is still a problem associated with orthodontic treatment, leading to the formation of white spot lesions; this is a grave concern to orthodontists and patients.

The overall prevalence of white spot lesions among orthodontic patients has been reported to be between 4.9% and 84%.1 When basic oral hygiene is poor, orthodontic appliances create areas of plaque stagnation, especially around brackets, bands, wires, and other attachments. Levels of acidogenic bacteria, present in the plaque, notably Streptococcus mutans (S mutans), are higher in orthodontic patients than in non-orthodontic patients.

This causes demineralization around the brackets and leads to white spot lesions. They are most prevalent around the cervical region of bands in the posterior region, whereas in the anterior region, the lateral incisors in both arches, followed by the canines, are most commonly affected.

Conditions

  • Malocclusion

Interventions

DRUG

Probiotic (L. brevis CD2 lozenges)

Each Lactobacillus brevis CD2 lozenge contains not less than 1 billion Colony Forming Unit of L. brevis CD2

DRUG

Placebo

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

Sponsors & Collaborators

  • Peoples University, Bhanpur, Bhopal

    collaborator OTHER

  • Next Gen Pharma India Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Upendra Jain, M. Orth. · Peoples College of Dental Sciences & Research Centre, Bhanpur, Bhopal, Madya Pradesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-08-31
Completion
2015-09-30

Countries

  • India

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02357771 on ClinicalTrials.gov