GingivitisNCT02597192
Clinical Effects of Bacillus Containing Oral Hygiene Products on Gingivitis: a Randomized Controlled Trial
A study testing probiotic oral hygiene products with Bacillus (PIP, Chrisal) and oral hygiene products without Bacillus in people with Gingivitis, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- probiotic oral hygiene products with Bacillus (PIP, Chrisal) and oral hygiene products without Bacillus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- patients with hematologic disorders, or other systemic illness
- pregnant and lactating females
- patients undergoing orthodontic treatment
- those with smoking habits were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Professor Doctor, Cukurova University Faculty of Dentistry
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.
Read the 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.
- Conditions
- Gingivitis
- Being tested
- probiotic oral hygiene products with Bacillus (PIP, Chrisal), oral hygiene products without Bacillus
- Keywords
- gingivitis, gingival inflammation, probiotics, Bacillus
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic oral hygiene products with Bacillus (PIP, Chrisal)Other
products with Bacillus probiotics
oral hygiene products without BacillusOther
products without Bacillus
| Study group | Role | What they receive |
|---|---|---|
| Active test group | Active comparator | probiotic oral hygiene products with Bacillus (PIP, Chrisal) Receives: Other: probiotic oral hygiene products with Bacillus (PIP, Chrisal) |
| Placebo group | Placebo comparator | oral hygiene products without Bacillus Receives: Other: oral hygiene products without Bacillus |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival index scores
Measured: 8weeks
Secondary outcomes (1)
plaque index scores
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Ozcelik, Cukurova University
- Investigators
- Onur Ozcelik, Professor, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597192
- Sponsor's protocol ID
- CukurovaU-7
- Status last verified
- Nov 2015
- First submitted
- 30 Oct 2015
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professor Doctor, Cukurova University Faculty of Dentistry
- ClinicalTrials.gov ID
- NCT02597192
- Acronym / sponsor ID
- CukurovaU-7
- Conditions
- Gingivitis
- Keywords
- gingivitis, gingival inflammation, probiotics, Bacillus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active test group | Active comparator | Other: probiotic oral hygiene products with Bacillus (PIP, Chrisal)probiotic oral hygiene products with Bacillus (PIP, Chrisal) |
| Placebo group | Placebo comparator | Other: oral hygiene products without Bacillusoral hygiene products without Bacillus |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- patients with hematologic disorders, or other systemic illness
- pregnant and lactating females
- patients undergoing orthodontic treatment
- those with smoking habits were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic oral hygiene products with Bacillus (PIP, Chrisal)products with Bacillus probiotics | Other | Active test group |
| oral hygiene products without Bacillusproducts without Bacillus | Other | Placebo group |
Primary outcome
gingival index scores
Time frame: 8weeks
1 secondary outcome
plaque index scores
Time frame: 8weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
Related trials for Gingivitis
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Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onur Ozcelik, Professor principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic oral hygiene products with Bacillus (PIP, Chrisal) and oral hygiene products without Bacillus in people with Gingivitis, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gingival index scores (time frame: 8weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.