Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients

Overview

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.

Full Title of Study: “Topical Application of Probiotic Lozenge to Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 2015

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)

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo Arm
    • Placebo Lozenges (4 Lozenges per day; 2 lozenges in morning and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
  • Experimental: Probiotic Arm
    • Lactobacillus brevis CD2 Lozenges (4 Lozenges per day; 2 lozenges in morning and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion Colony Forming Unit of L. brevis CD2

Clinical Trial Outcome Measures

Primary Measures

  • Changes in the levels of streptococcus Mutans in the plaque around orthodontic brackets.
    • Time Frame: 30 days

Participating in This Clinical Trial

Inclusion Criteria

  • Orthodontic treatment with the straight wire appliance (MBT, 0.022-in slot; 3M Unitek, Monro- via, Calif). – Complete permanent dentition (excluding third molars). – No chewing gum or mouthwash used in the last week and during the study. – Habit of brushing twice daily with fluoride toothpaste. Exclusion Criteria:

  • Patient with poor periodontal condition. – Patient with known medical condition e.g. subacute bacterial endocarditis, diabetes, valvular disease, anemia etc.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Next Gen Pharma India Pvt. Ltd.
  • Collaborator
    • Peoples University, Bhanpur, Bhopal
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Upendra Jain, M. Orth., Study Chair, Peoples College of Dental Sciences & Research Centre, Bhanpur, Bhopal, Madya Pradesh

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