GingivitisEarly Phase 1NCT02546206
Probiotic Yoghurt Effect on Experimental Gingivitis
A Early Phase 1 study testing Probiotic Yoghurt and Natural Yoghurt in people with Gingivitis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation. Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 16 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Probiotic Yoghurt and Natural Yoghurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2011to May 2012
- Phase
- Early Phase 1
- 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 16 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- No or minimal clinical signs of gingival inflammation
- Gingival Index ≤ 1
- No probing depth (Probing depth > 3 mm)
- No approximal attachment loss > 2 mm
- Non smokers
Who cannot join
- Systemic diseases
- Antibiotics and anti-inflammatory drugs within 3 months before the study
- Untreated caries lesions or local retention factors
- Mouth-breathing
- Allergies
- Previous probiotic supplements in diet
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, Faculty of Dentistry, Department of Periodontology
Istanbul, Sisli/Nisantasi, 34365
About this study
Official title: Influence of Probiotics on Clinical Parameters and GCF Levels of Interleukin-1β in Experimental Gingivitis: a Randomized Controlled Clinical Trial
The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation.
Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.
Read the detailed description
Probiotics are viable bacteria with scientifically confirmed health benefits for gastrointestinal system. However, there is paucity of information on its impact in periodontal disease. The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation.
Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.
- Conditions
- Gingivitis
- Being tested
- Probiotic Yoghurt, Natural Yoghurt
- Keywords
- Bifidobacterium, Gingivitis, Gingival crevicular fluid, Interleukin-1beta, Probiotics
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic YoghurtDietary supplement
Probiotic yoghurt consumption
Natural YoghurtDietary supplement
Natural yoghurt consumption
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Yoghurt | Experimental | Probiotic yoghurt consumption Receives: Dietary Supplement: Probiotic Yoghurt |
| Natural Yoghurt | Placebo comparator | Natural yoghurt consumption Receives: Dietary Supplement: Natural Yoghurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.
Measured: 33 days after yoghurt consumption
Secondary outcomes (2)
Gingival Index
Each of the buccal, mesial, lingual and distal surfaces of the gingival tissues is given a score of 0-3. (0 = Normal gingiva. 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation -marked redness and edema.)
Measured: 33 days after yoghurt consumption
Plaque Index
Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. (0 = No plaque in the gingival area. 1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. 2 = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. 3 = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. Tendency to spontaneous bleeding.)
Measured: 33 days after yoghurt consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionMay 2012
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 Marmara 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuğçe Yalnızoğlu, PhD, Principal investigator, Marmara University, Faculty of Dentistry, Department of PeriodontologyBahar Kuru, Prof Dr, Study director, Marmara University, Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546206
- Sponsor's protocol ID
- MAR-2011-10-11/14
- Status last verified
- Aug 2015
- First submitted
- 30 Aug 2015
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Probiotics on Clinical Parameters and GCF Levels of Interleukin-1β in Experimental Gingivitis: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02546206
- Acronym / sponsor ID
- MAR-2011-10-11/14
- Conditions
- Gingivitis
- Keywords
- Bifidobacterium, Gingivitis, Gingival crevicular fluid, Interleukin-1beta, Probiotics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Sep 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.
The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation.
Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.
Detailed description
Probiotics are viable bacteria with scientifically confirmed health benefits for gastrointestinal system. However, there is paucity of information on its impact in periodontal disease. The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation.
Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Yoghurt | Experimental | Dietary Supplement: Probiotic YoghurtProbiotic yoghurt consumption |
| Natural Yoghurt | Placebo comparator | Dietary Supplement: Natural YoghurtNatural yoghurt consumption |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- No or minimal clinical signs of gingival inflammation
- Gingival Index ≤ 1
- No probing depth (Probing depth > 3 mm)
- No approximal attachment loss > 2 mm
- Non smokers
Key exclusion criteria (6 listed)
- Systemic diseases
- Antibiotics and anti-inflammatory drugs within 3 months before the study
- Untreated caries lesions or local retention factors
- Mouth-breathing
- Allergies
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 YoghurtProbiotic yoghurt consumption | Dietary supplement | Probiotic Yoghurt |
| Natural YoghurtNatural yoghurt consumption | Dietary supplement | Natural Yoghurt |
Primary outcome
Bleeding on probing
Time frame: 33 days after yoghurt consumption
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.
2 secondary outcomes
Gingival Index
Time frame: 33 days after yoghurt consumption
Plaque Index
Time frame: 33 days after yoghurt consumption
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 10 Sep 2015.
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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.
Tuğçe Yalnızoğlu, PhD principal investigator
Marmara University, Faculty of Dentistry, Department of Periodontology
Bahar Kuru, Prof Dr study director
Marmara University, Faculty of Dentistry, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Probiotic Yoghurt and Natural Yoghurt in people with Gingivitis, run by Marmara 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 5 inclusion and 6 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 10 Sep 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bleeding on probing (time frame: 33 days after yoghurt consumption). 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 10 Sep 2015.