Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients

Phase 3

Completed

• Conditions: Malocclusion
• Interventions: Drug: Placebo; Drug: Probiotic (L. brevis CD2 lozenges)

• Registration Number: NCT02357771
• Lead Sponsor: Next Gen Pharma India Pvt. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-06
• Study Start: 2015-04
• Primary Completion: 2015-08
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	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)
Probiotic Arm	Probiotic (L. brevis CD2 lozenges)	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

Primary Outcome Measures

Name	Time	Method
Changes in the levels of streptococcus Mutans in the plaque around orthodontic brackets.	30 days

Trial Locations

Locations (1)

Department of Orthodontics & Dentofacial Orthopaedics, People College Of Dental Sciences & Research Centre, Bhanpur; 🇮🇳 Bhopal, Madhya Pradesh, India