Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients

NCT02357771 | Completed Phase 3

• 1 other identifier: BHO_PERIO-ODB_01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Keywords

misalignment of the two dental arches; mal-align teeth

Outcome Measures

Primary Outcomes (1)

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

  30 days

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

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

Probiotic Arm

EXPERIMENTAL

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)

Interventions

Probiotic (L. brevis CD2 lozenges) DRUG

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

Probiotic Arm

Placebo DRUG

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

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patient with poor periodontal condition.
• Patient with known medical condition e.g. subacute bacterial endocarditis, diabetes, valvular disease, anemia etc.

Sponsors & Collaborators

• Next Gen Pharma India Pvt. Ltd.: lead
• Peoples University, Bhanpur, Bhopal: collaborator

Study Sites (1)

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

Bhopal, Madhya Pradesh, 462037, India

Location

MeSH Terms

Conditions

Malocclusion

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Upendra Jain, M. Orth.

  Peoples College of Dental Sciences & Research Centre, Bhanpur, Bhopal, Madya Pradesh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 6, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

IN (1)