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

Professor Doctor, Cukurova University Faculty of Dentistry

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02597192
Enrollment
40
Registered
2015-11-05
Start date
2014-06-30
Completion date
2015-10-31
Last updated
2015-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis

Keywords

gingivitis, gingival inflammation, probiotics, Bacillus

Brief summary

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

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.

Interventions

OTHERprobiotic oral hygiene products with Bacillus (PIP, Chrisal)

products with Bacillus probiotics

OTHERoral hygiene products without Bacillus

products without Bacillus

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
gingival index scores8weeks

Secondary

MeasureTime frame
plaque index scores8weeks

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026