GingivitisNCT06437925
Effects of Probiotic Ayran on Gingivitis
A study testing probiotic ayran drink in people with Gingivitis and Probiotics, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: This study investigates the effects of daily consumption of probiotic ayran drink on gingival inflammation and the development of experimental gingivitis. Methods: A total of 54volunteer students were included in the present randomized, double-blind, placebo-controlled trial.The participants were divided… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Probiotics, Inflamed Gums
- What is being tested?
- probiotic ayran drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 15 Jun 2023
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemic healthy
- Subjects with gingivitis defined as a BOP sites ≥ 10% and PD ≤ 3 mm
- No radiographic bone loss
- Non-smoking participants
Who cannot join
- History of using antibiotics or anti-inflammatory drugs or probiotic preparations or food supplements in the last 6 months,
- Undergoing orthodontic treatment,
- Active carious lesions
- Mouth breathing
- History of allergy for milk or fermented milk products.
- Taking medications affecting the gingiva and/or oral mucosa
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Faculty of Dentistry
Adana
About this study
Official title: Effects of the Use of Probiotics Ayran on Gingival Inflammation: An Experimental Gingivitis Study
Objectives: This study investigates the effects of daily consumption of probiotic ayran drink on gingival inflammation and the development of experimental gingivitis.
Methods: A total of 54volunteer students were included in the present randomized, double-blind, placebo-controlled trial.The participants were divided randomly into two groups; The Control group consisted of 27 participants who consumed placebo ayran, while the 27 participants of the Test group consumed probiotic ayran (containing Lactobacillus acidophilus and Bifidobacterium bifidum) for 42 days twice a day.After 42 days, mechanical plaque control was interrupted for 5 days. The clinical parameters of gingivitis; Plaque index (PI), gingival index (GI), probing bleeding (BOP), probing depth (PPD) were recorded at baseline, day 42 (beginning of experimental gingivitis) and day 47 (the end of experimental gingivitis). At the same time points, gingival crevicular fluid had been collected for analysis of matrix metalloproteinase - 8 (MMP-8).
Read the detailed description
The most used and studied probiotics in the periodontal literature are lactobacillus and bifidobacterium. The current study aims to observe the effects of daily ayran consumption containing a probiotic combination of Lactobacillus acidophilus and Bifidobacterium bifidum on plaque development and gingival inflammation in an experimental gingivitis model of healthy individuals. The null hypothesis of this study using of probiotics has no additional benefit for periodontal health.
This study evaluates the effects of daily consumption of ayran containing a probiotic combination of Lactobacillus Acidophilus and Bifidobacterium Bifidum on plaque development and gingival status in healthy individuals with experimental gingivitis.
- Conditions
- Gingivitis, Probiotics, Inflamed Gums
- Being tested
- probiotic ayran drink, Placebo ayran drink
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic ayran drinkDietary supplement
The test group has received probiotic ayran drink for 6 weeks
Placebo ayran drinkDietary supplement
The control group has received placebo ayran drink for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic ayran drink | Experimental | The participants in this experimental group will use probiotic containing ayran for 42 days and then will be subjected to 5 days of experimental gingivitis. Receives: Dietary Supplement: probiotic ayran drink |
| Placebo ayran drink | Placebo comparator | The participants in this control group will use control ayran without probiotics for 42 days and then will be subjected to 5 days of experimental gingivitis. Receives: Dietary Supplement: Placebo ayran drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
PI was scored from 0 to 5 according to the color change obtained with the Mira-2 solution
Measured: Plaque index will be recorded at baseline, at day 42 and 47
Gingival index
GI is graded by visual assessment and mechanical stimulation of the gingival tissues, scoring the gingival condition according to the criteria
Measured: Gingival index will be recorded at baseline, at day 42 and 47
Bleeding on probing
The probing bleeding (BOP) index was determined by the presence/absence of bleeding ≈30 seconds after probing
Measured: BOP will be recorded at baseline, at day 42 and 47
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start15 Jan 2023
- Primary completion15 Apr 2023
- Study completion15 Jun 2023
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenk Haytac, Cukurova University
- Investigators
- Cenk Haytac, phd, Principal investigator, Professor Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437925
- Sponsor's protocol ID
- Cukurova University-1
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Use of Probiotics Ayran on Gingival Inflammation: An Experimental Gingivitis Study
- ClinicalTrials.gov ID
- NCT06437925
- Acronym / sponsor ID
- Cukurova University-1
- Conditions
- Gingivitis, Probiotics, Inflamed Gums
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 31 May 2024 (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.
Objectives: This study investigates the effects of daily consumption of probiotic ayran drink on gingival inflammation and the development of experimental gingivitis.
Methods: A total of 54volunteer students were included in the present randomized, double-blind, placebo-controlled trial.The participants were divided randomly into two groups; The Control group consisted of 27 participants who consumed placebo ayran, while the 27 participants of the Test group consumed probiotic ayran (containing Lactobacillus acidophilus and Bifidobacterium bifidum) for 42 days twice a day.After 42 days, mechanical plaque control was interrupted for 5 days. The clinical parameters of gingivitis; Plaque index (PI), gingival index (GI), probing bleeding (BOP), probing depth (PPD) were recorded at baseline, day 42 (beginning of experimental gingivitis) and day 47 (the end of experimental gingivitis). At the same time points, gingival crevicular fluid had been collected for analysis of matrix metalloproteinase - 8 (MMP-8).
Detailed description
The most used and studied probiotics in the periodontal literature are lactobacillus and bifidobacterium. The current study aims to observe the effects of daily ayran consumption containing a probiotic combination of Lactobacillus acidophilus and Bifidobacterium bifidum on plaque development and gingival inflammation in an experimental gingivitis model of healthy individuals. The null hypothesis of this study using of probiotics has no additional benefit for periodontal health.
This study evaluates the effects of daily consumption of ayran containing a probiotic combination of Lactobacillus Acidophilus and Bifidobacterium Bifidum on plaque development and gingival status in healthy individuals with experimental gingivitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic ayran drink | Experimental | Dietary Supplement: probiotic ayran drinkThe participants in this experimental group will use probiotic containing ayran for 42 days and then will be subjected to 5 days of experimental gingivitis. |
| Placebo ayran drink | Placebo comparator | Dietary Supplement: Placebo ayran drinkThe participants in this control group will use control ayran without probiotics for 42 days and then will be subjected to 5 days of experimental gingivitis. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Systemic healthy
- Subjects with gingivitis defined as a BOP sites ≥ 10% and PD ≤ 3 mm
- No radiographic bone loss
- Non-smoking participants
Key exclusion criteria (6 listed)
- History of using antibiotics or anti-inflammatory drugs or probiotic preparations or food supplements in the last 6 months,
- Undergoing orthodontic treatment,
- Active carious lesions
- Mouth breathing
- History of allergy for milk or fermented milk products.
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 ayran drinkThe test group has received probiotic ayran drink for 6 weeks | Dietary supplement | Probiotic ayran drink |
| Placebo ayran drinkThe control group has received placebo ayran drink for 6 weeks | Dietary supplement | Placebo ayran drink |
Primary outcome
Plaque index
Time frame: Plaque index will be recorded at baseline, at day 42 and 47
PI was scored from 0 to 5 according to the color change obtained with the Mira-2 solution
Gingival index
Time frame: Gingival index will be recorded at baseline, at day 42 and 47
GI is graded by visual assessment and mechanical stimulation of the gingival tissues, scoring the gingival condition according to the criteria
Bleeding on probing
Time frame: BOP will be recorded at baseline, at day 42 and 47
The probing bleeding (BOP) index was determined by the presence/absence of bleeding ≈30 seconds after probing
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 31 May 2024.
- Individual participant dataSharing planned: Yes. The data will be shared upon request
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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.
Cenk Haytac, phd principal investigator
Professor Doctor
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 ayran drink in people with Gingivitis and Probiotics, 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 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 31 May 2024. 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?
Plaque index (time frame: Plaque index will be recorded at baseline, at day 42 and 47). The study lists 3 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 31 May 2024.