Periodontal DiseasestropipdNCT05211219
The Role of Probiotics in Periodontal Disease
A study testing Probiotics, AOÇ Kefir and Food without additional food supplements in people with Periodontal Diseases, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial summary
In this randomized controlled trial, it was aimed to evaluate the effect of probiotics (chewable tablets) and kefir consumption in the initial periodontal treatment of periodontitis patients on the change of oral microbiota and treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Probiotics, AOÇ Kefir and Food without additional food supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 Jan 2021to 28 May 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy
- Individuals over 18
- Periodontitis (4-6 mm pockets) patients with 3 teeth in each half of the jaws except wisdom tooth
- Non-smoker
- Not using probiotic tablets/capsules and consuming no more than 3-4 probiotic food.
Who cannot join
- Antibiotic use within 6 months.
- Breastfeeding or pregnancy.
- Acute oral lesions or necrotizing ulcerative periodontitis
- Diabetes, rheumatic fever, lung, kidney disease history and drug use that will affect periodontal tissues
- Patients who smoke or who did not stop until last year
- Use of probiotics tablets or capsules
- Probiotic food consumption not more than 3-4 times a week
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gazi University Faculty of Dentistry
Ankara, 06490
Tuğba Şahin
Ankara, 06560
About this study
Official title: The Role of Probiotics in Preventing Dysbiosis in Periodontal Disease
In this randomized controlled trial, it was aimed to evaluate the effect of probiotics (chewable tablets) and kefir consumption in the initial periodontal treatment of periodontitis patients on the change of oral microbiota and treatment. In this clinical trial, 36 systemically healthy volunteers who were diagnosed with periodontitis who were admitted to Gazi University Faculty of Dentistry, Department of Periodontology were included. Besides the inclusion criteria, the nutritional habits of the patients were evaluated by questionnaire. For diagnosis, plaque index, gingival index, bleeding on probing, periodontal probing depth and clinical attachment level were examined. Patients were randomly divided into 3 groups; probiotic, kefir and control group. Following the periodontal diagnosis, clinical index records of the patients and subgingival microbial samples were obtained. The supragingival plaque sample was removed and the subgingival microbial dental plaque sample was gently taken with a sterile Gracey curette. In the same session, periodontal initial treatment was started. According to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements. Periodontal indexes were repeated in the 1st and 3rd months. Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia (T. forsythia), Porphyromonas gingivalis (P. gingivalis), and Treponema denticola (T. denticola).
- Conditions
- Periodontal Diseases
- Being tested
- Probiotics, AOÇ Kefir, Food without additional food supplements
- Keywords
- Periodontal disease, Probiotics, Prebiotics
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Also called Probest Defense
According to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; the probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements.
AOÇ KefirDietary supplement
AOÇ Kefir
Food without additional food supplementsOther
Food without additional food supplements
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | The probiotics group was advised to consume a chewable tablet once a day in 14 days. Receives: Dietary Supplement: Probiotics |
| Kefir | Experimental | The kefir group was advised to consume kefir as a liquid once a day in 14 days. Receives: Dietary Supplement: AOÇ Kefir |
| Control | Other | the control group was advised without additional food supplements. Receives: Other: Food without additional food supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal probing depth
the distance from the gingival margin to pocket base.
Measured: Baseline
Periodontal probing depth
the distance from the gingival margin to pocket base.
Measured: 1st month
Periodontal probing depth
the distance from the gingival margin to pocket base.
Measured: 3rd month
Gingival index
It is an index that shows the severity and quantity of gingival inflammation.
Measured: Baseline
Gingival index
It is an index that shows the severity and quantity of gingival inflammation.
Measured: 1st month
Gingival index
It is an index that shows the severity and quantity of gingival inflammation.
Measured: 3rd month
Microbiological sample
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Measured: Baseline
Microbiological sample
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Measured: 1st month
Microbiological sample
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Measured: 3rd month
Plaque index
It is an index that shows the amount of microbial dental plaque on the teeth.
Measured: Baseline
Plaque index
It is an index that shows the amount of microbial dental plaque on the teeth.
Measured: 1st month
Plaque index
It is an index that shows the amount of microbial dental plaque on the teeth.
Measured: 3rd month
Bleeding on probing
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
Measured: Baseline
Bleeding on probing
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
Measured: 1st month
Bleeding on probing
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
Measured: 3rd month
Secondary outcomes (3)
Clinical attachment level
The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.
Measured: Baseline
Clinical attachment level
The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.
Measured: 1st month
Clinical attachment level
The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start7 Jan 2021
- Primary completion7 Jan 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurdan Ozmeric, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211219
- Sponsor's protocol ID
- 03/2020-18
- Other IDs
- 6268
- Acronym
- tropipd
- Status last verified
- Feb 2023
- First submitted
- 26 Nov 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Probiotics in Preventing Dysbiosis in Periodontal Disease
- ClinicalTrials.gov ID
- NCT05211219
- Acronym / sponsor ID
- tropipd / 03/2020-18
- Conditions
- Periodontal Diseases
- Keywords
- Periodontal disease, Probiotics, Prebiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 27 Jan 2022 (actual)
- 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.
In this randomized controlled trial, it was aimed to evaluate the effect of probiotics (chewable tablets) and kefir consumption in the initial periodontal treatment of periodontitis patients on the change of oral microbiota and treatment. In this clinical trial, 36 systemically healthy volunteers who were diagnosed with periodontitis who were admitted to Gazi University Faculty of Dentistry, Department of Periodontology were included. Besides the inclusion criteria, the nutritional habits of the patients were evaluated by questionnaire. For diagnosis, plaque index, gingival index, bleeding on probing, periodontal probing depth and clinical attachment level were examined. Patients were randomly divided into 3 groups; probiotic, kefir and control group. Following the periodontal diagnosis, clinical index records of the patients and subgingival microbial samples were obtained. The supragingival plaque sample was removed and the subgingival microbial dental plaque sample was gently taken with a sterile Gracey curette. In the same session, periodontal initial treatment was started. According to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements. Periodontal indexes were repeated in the 1st and 3rd months. Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia (T. forsythia), Porphyromonas gingivalis (P. gingivalis), and Treponema denticola (T. denticola).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: ProbioticsThe probiotics group was advised to consume a chewable tablet once a day in 14 days. |
| Kefir | Experimental | Dietary Supplement: AOÇ KefirThe kefir group was advised to consume kefir as a liquid once a day in 14 days. |
| Control | Other | Other: Food without additional food supplementsthe control group was advised without additional food supplements. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy
- Individuals over 18
- Periodontitis (4-6 mm pockets) patients with 3 teeth in each half of the jaws except wisdom tooth
- Non-smoker
- Not using probiotic tablets/capsules and consuming no more than 3-4 probiotic food.
Key exclusion criteria (7 listed)
- Antibiotic use within 6 months.
- Breastfeeding or pregnancy.
- Acute oral lesions or necrotizing ulcerative periodontitis
- Diabetes, rheumatic fever, lung, kidney disease history and drug use that will affect periodontal tissues
- Patients who smoke or who did not stop until last year
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 |
|---|---|---|
| ProbioticsAlso: Probest DefenseAccording to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; the probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements. | Dietary supplement | Probiotics |
| AOÇ KefirAOÇ Kefir | Dietary supplement | Kefir |
| Food without additional food supplementsFood without additional food supplements | Other | Control |
Primary outcome
Periodontal probing depth
Time frame: Baseline
the distance from the gingival margin to pocket base.
Periodontal probing depth
Time frame: 1st month
the distance from the gingival margin to pocket base.
Periodontal probing depth
Time frame: 3rd month
the distance from the gingival margin to pocket base.
Gingival index
Time frame: Baseline
It is an index that shows the severity and quantity of gingival inflammation.
Gingival index
Time frame: 1st month
It is an index that shows the severity and quantity of gingival inflammation.
Gingival index
Time frame: 3rd month
It is an index that shows the severity and quantity of gingival inflammation.
Microbiological sample
Time frame: Baseline
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Microbiological sample
Time frame: 1st month
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Microbiological sample
Time frame: 3rd month
Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.
Plaque index
Time frame: Baseline
It is an index that shows the amount of microbial dental plaque on the teeth.
Plaque index
Time frame: 1st month
It is an index that shows the amount of microbial dental plaque on the teeth.
Plaque index
Time frame: 3rd month
It is an index that shows the amount of microbial dental plaque on the teeth.
Bleeding on probing
Time frame: Baseline
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
Bleeding on probing
Time frame: 1st month
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
Bleeding on probing
Time frame: 3rd month
Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
3 secondary outcomes
Clinical attachment level
Time frame: Baseline
Clinical attachment level
Time frame: 1st month
Clinical attachment level
Time frame: 3rd month
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 15 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics, AOÇ Kefir and Food without additional food supplements in people with Periodontal Diseases, run by Gazi University at 2 sites 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 7 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Periodontal probing depth (time frame: Baseline). The study lists 15 primary outcomes in all. 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 15 Feb 2023.