Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients

Topical Application of Probiotic Lozenge to Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Drug: Placebo; Drug: Probiotic (L. brevis CD2 lozenges)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Madhya Pradesh
    • Bhopal, Madhya Pradesh, India, 462037
      • Department of Orthodontics & Dentofacial Orthopaedics, People College Of Dental Sciences & Research Centre, Bhanpur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Drug: Placebo; 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	Drug: Probiotic (L. brevis CD2 lozenges); Each Lactobacillus brevis CD2 lozenge contains not less than 1 billion Colony Forming Unit of L. brevis CD2

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Next Gen Pharma India Pvt. Ltd.
• Collaborators: Peoples University, Bhanpur, Bhopal
• Investigators: Study Chair: Upendra Jain, M. Orth., Peoples College of Dental Sciences & Research Centre, Bhanpur, Bhopal, Madya Pradesh

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 5, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: misalignment of the two dental arches; mal-align teeth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: BHO_PERIO-ODB_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No