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

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
probiotic oral hygiene products with Bacillus (PIP, Chrisal)
oral hygiene products without Bacillus
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring gingivitis, gingival inflammation, probiotics, Bacillus

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active test group

Placebo group

Arm Description

probiotic oral hygiene products with Bacillus (PIP, Chrisal)

oral hygiene products without Bacillus

Outcomes

Primary Outcome Measures

gingival index scores

Secondary Outcome Measures

plaque index scores

Full Information

First Posted
October 30, 2015
Last Updated
November 3, 2015
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT02597192
Brief Title
Clinical Effects of Bacillus Containing Oral Hygiene Products on Gingivitis: a Randomized Controlled Trial
Official Title
Professor Doctor, Cukurova University Faculty of Dentistry
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
gingivitis, gingival inflammation, probiotics, Bacillus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active test group
Arm Type
Active Comparator
Arm Description
probiotic oral hygiene products with Bacillus (PIP, Chrisal)
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
oral hygiene products without Bacillus
Intervention Type
Other
Intervention Name(s)
probiotic oral hygiene products with Bacillus (PIP, Chrisal)
Intervention Description
products with Bacillus probiotics
Intervention Type
Other
Intervention Name(s)
oral hygiene products without Bacillus
Intervention Description
products without Bacillus
Primary Outcome Measure Information:
Title
gingival index scores
Time Frame
8weeks
Secondary Outcome Measure Information:
Title
plaque index scores
Time Frame
8weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onur Ozcelik, Professor
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01330
Country
Turkey

12. IPD Sharing Statement

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

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