Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Changes in the levels of streptococcus Mutans in the plaque around orthodontic brackets. [30 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Orthodontic treatment with the straight wire appliance (MBT, 0.022-in slot; 3M Unitek, Monro- via, Calif).
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Complete permanent dentition (excluding third molars).
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No chewing gum or mouthwash used in the last week and during the study.
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Habit of brushing twice daily with fluoride toothpaste.
Exclusion Criteria:
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Patient with poor periodontal condition.
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Patient with known medical condition e.g. subacute bacterial endocarditis, diabetes, valvular disease, anemia etc.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Orthodontics & Dentofacial Orthopaedics, People College Of Dental Sciences & Research Centre, Bhanpur | Bhopal | Madhya Pradesh | India | 462037 |
Sponsors and Collaborators
- Next Gen Pharma India Pvt. Ltd.
- Peoples University, Bhanpur, Bhopal
Investigators
- Study Chair: Upendra Jain, M. Orth., Peoples College of Dental Sciences & Research Centre, Bhanpur, Bhopal, Madya Pradesh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BHO_PERIO-ODB_01