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Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients

Primary Purpose

Malocclusion

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Probiotic (L. brevis CD2 lozenges)
Placebo
Sponsored by
Next Gen Pharma India Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring misalignment of the two dental arches, mal-align teeth

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Orthodontics & Dentofacial Orthopaedics, People College Of Dental Sciences & Research Centre, Bhanpur

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Arm

Probiotic Arm

Arm 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)

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

Outcomes

Primary Outcome Measures

Changes in the levels of streptococcus Mutans in the plaque around orthodontic brackets.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2015
Last Updated
September 22, 2015
Sponsor
Next Gen Pharma India Pvt. Ltd.
Collaborators
Peoples University, Bhanpur, Bhopal
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1. Study Identification

Unique Protocol Identification Number
NCT02357771
Brief Title
Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients
Official Title
Topical Application of Probiotic Lozenge to Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Next Gen Pharma India Pvt. Ltd.
Collaborators
Peoples University, Bhanpur, Bhopal

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
misalignment of the two dental arches, mal-align teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm 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)
Arm Title
Probiotic Arm
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Probiotic (L. brevis CD2 lozenges)
Intervention Description
Each Lactobacillus brevis CD2 lozenge contains not less than 1 billion Colony Forming Unit of L. brevis CD2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
Primary Outcome Measure Information:
Title
Changes in the levels of streptococcus Mutans in the plaque around orthodontic brackets.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Upendra Jain, M. Orth.
Organizational Affiliation
Peoples College of Dental Sciences & Research Centre, Bhanpur, Bhopal, Madya Pradesh
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthodontics & Dentofacial Orthopaedics, People College Of Dental Sciences & Research Centre, Bhanpur
City
Bhopal
State/Province
Madhya Pradesh
ZIP/Postal Code
462037
Country
India

12. IPD Sharing Statement

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Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients

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