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OpenTrials
Completed

NCT Number: NCT02357771

Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Bhopal, Madhya Pradesh, 462037, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic (L. brevis CD2 lozenges)

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Next Gen Pharma India Pvt. Ltd.

Industry

Collaborators

  • Peoples University, Bhanpur, Bhopal

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2015
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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