An interventional study of probiotic oral hygiene products with Bacillus (PIP, Chrisal) and oral hygiene products without Bacillus in Gingivitis, sponsored by Cukurova University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-05.
Sponsored by Cukurova University · Not applicable, Interventional, and Treatment
Aim: Evaluating the clinical effects of a Bacillus subtilis, Bacillus megaterium and Bacillus pumulus containing toothpaste, mouthwash and toothbrush cleaner versus a placebo in patients with generalized gingivitis.
Materials and methods: In this double-blind placebo-controlled randomized clinical trial generalized gingivitis patients who were systemically healthy and who did not smoke were included. They used a placebo or probiotic Bacillus containing toothbrush cleaner for 8 weeks. Primary outcome measures of interest were plaque and gingivitis index, secondary outcome measures were pocket probing depth and bleeding on probing.
The administration of micro-organisms to improve the human health was already promoted by the Nobel prizewinning scientist Eli Metchnikoff in the beginning of the 20th century. However, it took several decades for this subject to become a topic of interest in medicine. At this moment these micro-organisms are called "probiotics" and defined as "living microorganisms which, when administered in adequate amounts, confer a health benefit for the host" (http://www.who.int/foodsafety/publications/fs_management/en/probiotics.pdf). Over the past decade probiotics have been extensively investigated from the perspective of oral health. It was shown that probiotics have the capacity to reduce mutans streptococci counts in saliva and/or plaque during their usage, that they have a positive influence on bad breath and that they can improve the results of scaling and root planing in periodontitis patients. A positive effect of probiotic usage on plaque accumulation and gingivitis measurements in gingivitis patients was also shown.To the investigators knowledge, at this moment no trials are available describing the effect of other probiotic genera on gingivitis. Since it is clear that probiotic effects are strain, dosage and mode of application dependent, the aim of this study was to evaluate the use of a probiotic toothpaste, mouthwash and toothbrush cleaner with Bacillus subtilis, Bacillus megaterium, and Bacillus pumulus versus a placebo in patients with generalized gingivitis.
590 studies on the registry are indexed under Gingivitis; 105 are open to participants now.
This study's enrollment of 40 is below the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Cukurova University is the lead sponsor of 247 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
probiotic oral hygiene products with Bacillus (PIP, Chrisal)
Other: probiotic oral hygiene products with Bacillus (PIP, Chrisal)
oral hygiene products without Bacillus
Other: oral hygiene products without Bacillus
products with Bacillus probiotics
products without Bacillus
gingival index scores
Time frame: 8weeks
plaque index scores
Time frame: 8weeks
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Cukurova University