Trial | NCT02357771  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
Study Started
Apr 30
2015
Primary Completion
Aug 31
2015
Study Completion
Sep 30
2015
Last Update
Sep 23
2015
Estimate

Drug Probiotic (L. brevis CD2 lozenges)

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

Drug Placebo

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

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)

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

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.
No Results Posted