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

Sponsors

Lead Sponsor: Next Gen Pharma India Pvt. Ltd.

Collaborator: Peoples University, Bhanpur, Bhopal

Source 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.

Overall Status Completed
Start Date 2015-04-01
Completion Date 2015-09-01
Primary Completion Date 2015-08-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in the levels of streptococcus Mutans in the plaque around orthodontic brackets. 30 days
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Probiotic (L. brevis CD2 lozenges)

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

Arm Group Label: Probiotic Arm

Intervention Type: Drug

Intervention Name: Placebo

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

Arm Group Label: Placebo Arm

Eligibility

Criteria:

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:

All

Minimum Age:

18 Years

Maximum Age:

40 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Upendra Jain, M. Orth. Study Chair Peoples College of Dental Sciences & Research Centre, Bhanpur, Bhopal, Madya Pradesh
Location
Facility: Department of Orthodontics & Dentofacial Orthopaedics, People College Of Dental Sciences & Research Centre, Bhanpur
Location Countries

India

Verification Date

2015-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo Arm

Type: Placebo Comparator

Description: 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)

Label: Probiotic Arm

Type: Experimental

Description: 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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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