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Clinical Trials/NCT02597192
NCT02597192CompletedNot Applicable

Professor Doctor, Cukurova University Faculty of Dentistry

Cukurova University1 site in 1 country40 target enrollmentStarted: June 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
gingival index scores

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts 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.

Arms & Interventions

Active test group

Active Comparator

probiotic oral hygiene products with Bacillus (PIP, Chrisal)

Intervention: probiotic oral hygiene products with Bacillus (PIP, Chrisal) (Other)

Placebo group

Placebo Comparator

oral hygiene products without Bacillus

Intervention: oral hygiene products without Bacillus (Other)

Outcomes

Primary Outcomes

gingival index scores

Time Frame: 8weeks

Secondary Outcomes

  • plaque index scores(8weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Onur Ozcelik

Professor

Cukurova University

Study Sites (1)

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