A Phase 3 interventional study of Probiotic (L. brevis CD2 lozenges) and Placebo in Malocclusion, sponsored by Next Gen Pharma India Pvt. Ltd.. Completed at 1 site in India. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2015-09-23.
Sponsored by Next Gen Pharma India Pvt. Ltd. · Phase 3, Interventional, and Treatment
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.
457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's enrollment of 30 is below the median of 36 across 372 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Next Gen Pharma India Pvt. Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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)
Each Lactobacillus brevis CD2 lozenge contains not less than 1 billion Colony Forming Unit of L. brevis CD2
Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
Changes in the levels of streptococcus Mutans in the plaque around orthodontic brackets.
Time frame: 30 days
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Next Gen Pharma India Pvt. Ltd.