Clinical Effects of Bacillus Containing Oral Hygiene Products on Gingivitis: a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Professor Doctor, Cukurova University Faculty of Dentistry

Conditions
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Gingivitis

Intervention / Treatment
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* Other: probiotic oral hygiene products with Bacillus (PIP, Chrisal)
* Other: oral hygiene products without Bacillus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with plaque-induced gingivitis a pocket probing depth not more than 5 mm at least 20 natural teeth no history of periodontal therapy or previous use of antibiotics or anti-inflammatory medication within the preceding 6 months Exclusion Criteria: patients with hematologic disorders, or other systemic illness pregnant and lactating females patients undergoing orthodontic treatment those with smoking habits were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active test group<br>probiotic oral hygiene products with Bacillus (PIP, Chrisal) | Other: probiotic oral hygiene products with Bacillus (PIP, Chrisal)<br>* products with Bacillus probiotics<br>|
| Placebo Comparator: Placebo group<br>oral hygiene products without Bacillus | Other: oral hygiene products without Bacillus<br>* products without Bacillus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gingival index scores |  | 8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plaque index scores |  | 8weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gingivitis, gingival inflammation, probiotics, Bacillus