Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357771
• Other study ID #: BHO_PERIO-ODB_01
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2015
• Last updated: September 22, 2015
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Next Gen Pharma India Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malocclusion

Intervention

Drug:
• Probiotic (L. brevis CD2 lozenges)
Each Lactobacillus brevis CD2 lozenge contains not less than 1 billion Colony Forming Unit of L. brevis CD2
• Placebo
Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Locations

Country	Name	City	State
India	Department of Orthodontics & Dentofacial Orthopaedics, People College Of Dental Sciences & Research Centre, Bhanpur	Bhopal	Madhya Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
Next Gen Pharma India Pvt. Ltd.	Peoples College Of Dental Sciences & Research Centre, Bhanpur, Bhopal (MP)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the levels of streptococcus Mutans in the plaque around orthodontic brackets.		30 days	No