Periodontal DiseasesNCT06514664
Evaluation of the Effects of Probiotic Toothpastes on Periodontal Health
A study testing Using Probiotic Toothpaste in people with Periodontal Diseases and Periodontitis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This controlled, randomized clinical study aims to evaluate the possible effects of probiotic toothpaste on the success of periodontal treatment in smokers and non-smokers with clinical data. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Gingivitis
- What is being tested?
- Using Probiotic Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2023to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Pocket depth ≥ 4 mm and clinical attachment loss ≥ 1 mm in at least 5 teeth, bleeding score on probing 20%, and widespread bone loss that can be diagnosed radiographically.
- Absence of any systemic disease
- Having at least 14 natural teeth
- Diagnosing periodontitis as a result of clinical and radiological examinations
- Volunteering to participate in the research and signing the consent form prepared in accordance with the Declaration of Helsinki.
Who cannot join
- Being outside the specified age range
- Being pregnant or lactating
- Having used antibiotics for any reason in the last 3 months
- Having had periodontal treatment in the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
Kütahya, 43100
About this study
This controlled, randomized clinical study aims to evaluate the possible effects of probiotic toothpaste on the success of periodontal treatment in smokers and non-smokers with clinical data.
The main question(s) it aims to answer are:
Does applying probiotic toothpaste in addition to periodontal treatment have a positive effect on the gingival of periodontitis patients who are smokers and non-smokers?
The study includes four groups; Group 1: Use of probiotic toothpaste + smoking patient Group 2: Use of regular toothpaste + smoking patient Group 3: Use of probiotic toothpaste + non-smoking patient Group 4: Use of regular toothpaste + non-smoking patient
Read the detailed description
Periodontitis is characterized by the progressive destruction of all periodontium structures that support the teeth, including periodontal connective tissue and alveolar bone, caused by dental biofilm, resulting in irreversible damage. Severe periodontitis has become a public health problem that affects approximately 11% of the world's population, that is, 743 million people. When left untreated, it reduces the quality of life and leads to tooth loss. In addition to being a common cause of tooth loss, severe periodontitis has been reported to be a predisposing factor in the development of major systemic diseases such as atherosclerosis, cerebrovascular disease, diabetes, rheumatoid arthritis, Alzheimer's disease and some cancers, and increases the risk of adverse pregnancies (low birth weight, preterm birth). Periodontal inflammation is caused by the presence of gram-negative anaerobic bacteria called "red complex" in the subgingival plaque. Red complex bacteria include Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola, which are responsible for the onset and development of periodontal disease and are found predominantly in the deep periodontal pockets of patients with periodontitis.
In addition, genetic and environmental factors may increase an individual's susceptibility to periodontal disease. The patient's smoking and diabetes mellitus are risk factors for periodontitis. Smoking is the most important environmental risk factor for periodontitis. When subgingival biofilms of nonsmokers/former smokers were compared with smokers, smokers exhibited a higher prevalence of red complex bacteria. Additionally, it has been reported that the potential negative effect of smoking on immune cells, especially neutrophils, makes the individual more susceptible to periodontitis. It has been observed that periodontitis patients who smoke have more alveolar bone and attachment loss than non-smokers. The main goal of periodontal treatment in patients diagnosed with periodontitis is based on removing subgingival biofilm and dental calculus. Before applying surgical periodontal treatment, which is the second step, the first step is non-surgical periodontal treatment and is a prerequisite for deciding to proceed to the surgical stage. In addition to non-surgical periodontal treatment, Local and/or systemic antibiotics, anti-inflammatory drugs, photodynamic therapy, laser, probiotics, prebiotics and synbiotics, statins, ozone therapy, epigenetic therapy, and omega 3-6 can be used. Probiotics modulate the oral microbiota by integrating beneficial bacteria into oral biofilms and preventing the treatment of oral microbial diseases. Probiotics are defined as live microorganisms that provide health benefits when administered in sufficient amounts. The most common probiotic bacteria are Lactobacillus and Bifidobacterium species. Probiotic bifidobacteria have antimicrobial activity against periodontal pathogenic bacteria P. gingivalis and Fusobacterium nucleatum. In an in vitro study by Jasberg et al., it was shown that species belonging to the genus Bifidobacterium could strongly adhere to the subgingival biofilm and significantly reduce the number of Porphyromonas gingivalis. All bifidobacteria integrated well into subgingival biofilms consisting of Porphyromonas gingivalis, Actinomyces naeslundii, and Fusobacterium nucleatum, but only significantly reduced the number of P.gingivalis in biofilms. In the systematic review and meta-analysis evaluating the additional use of probiotics in patients with chronic periodontitis, seven clinical studies evaluating the effectiveness of probiotics as an aid in scaling and root planing were included. While four studies showed additional benefits of probiotics in reducing pocket depth and providing clinical attachment gain, Three studies showed no significant differences. In addition, the difference between the average clinical attachment gain of the patients during the long-term follow-up phases was found to be significant. Today, studies show that probiotic toothpaste effectively prevents infectious diseases such as caries or periodontal disease. However, there are no studies on the effect of smoking on the effectiveness of toothpaste.
Probiotic Toothpaste Content: Glycerin, Hydrated Silica, Aqua, Aloe Barbedensiz, Leaf Juice, Citric Acid, Potassium Sorbate, Sodium Benzoate, Xanthan Gum, B.Coagulans BC4, Xylitol, Sodium Coco-Sulfate, Sodium Hydroxide, Lavandula AngusTifolia (Lavender) Contains Oil (Linalool).
OHIP-14 survey: The effect of the treatment on the patient's quality of life is evaluated with a 14-question survey asked before and one month after non-surgical periodontal treatment.
Periodontal indexes will be taken from all patients in the study group after taking systemic and dental anamnesis. At the first examination session, study samples will be taken, clinical periodontal measurements (plaque index, gingival index, bleeding index, pocket depth, attachment loss, were used to evaluate the periodontal status in 6 regions of each tooth (mesio-buccal, buccal, disto-buccal, disto-palatal, palatal, mesio-palatal) with the Williams periodontal probe (Hu-Friedy, USA) will be measured and recorded) and the oral health effective profile-14 (OHIP-14) questionnaire will be recorded. Afterward, all teeth will be cleaned with an ultrasonic device, and oral hygiene training will be given to the patients. Patients will be taught how to brush their teeth using the modified Bass technique and how to use an interdental brush. In the second session, tooth brushing and interdental brush usage will be checked, and if sufficient, dental floss training will be given; if inadequate, brush usage will be explained again.
- Conditions
- Periodontal Diseases, Periodontitis, Gingivitis
- Being tested
- Using Probiotic Toothpaste
- Medical subject headings
- Periodontal Diseases, Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using Probiotic ToothpasteOther
Scaling and root planing (Phase 1 = non-surgical periodontal treatment) are performed in all patient groups.
Depending on the study groups, regular or probiotic toothpaste will be used. Toothpaste is instructed to be used twice a day
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Use of probiotic toothpaste + smoking patient Receives: Other: Using Probiotic Toothpaste |
| Group 2 | No intervention | Use of regular toothpaste + smoking patient |
| Group 3 | Experimental | Use of probiotic toothpaste + non-smoking patient Receives: Other: Using Probiotic Toothpaste |
| Group 4 | No intervention | Use of regular toothpaste + non-smoking patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket depth changes
Periodontal pocket depth changes will be measured with periodontal probe at baseline and third month postoperatively
Measured: 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start10 Apr 2023
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
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 Kutahya Health Sciences 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
- Model description
- Randomized Controlled Clinical Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berceste Guler, Kutahya Health Sciences University
- Investigators
- Berceste Guler Ayyildiz, Principal investigator, Kutahya Health Science UniversityAhu Uraz Corekci, Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514664
- Sponsor's protocol ID
- 2023-03/08
- Status last verified
- Mar 2025
- First submitted
- 15 Jul 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If contacted, the principal researcher's evaluation will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Probiotic Toothpastes on Periodontal Health
- ClinicalTrials.gov ID
- NCT06514664
- Acronym / sponsor ID
- 2023-03/08
- Conditions
- Periodontal Diseases, Periodontitis, Gingivitis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 23 Jul 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.
This controlled, randomized clinical study aims to evaluate the possible effects of probiotic toothpaste on the success of periodontal treatment in smokers and non-smokers with clinical data.
The main question(s) it aims to answer are:
Does applying probiotic toothpaste in addition to periodontal treatment have a positive effect on the gingival of periodontitis patients who are smokers and non-smokers?
The study includes four groups; Group 1: Use of probiotic toothpaste + smoking patient Group 2: Use of regular toothpaste + smoking patient Group 3: Use of probiotic toothpaste + non-smoking patient Group 4: Use of regular toothpaste + non-smoking patient
Detailed description
Periodontitis is characterized by the progressive destruction of all periodontium structures that support the teeth, including periodontal connective tissue and alveolar bone, caused by dental biofilm, resulting in irreversible damage. Severe periodontitis has become a public health problem that affects approximately 11% of the world's population, that is, 743 million people. When left untreated, it reduces the quality of life and leads to tooth loss. In addition to being a common cause of tooth loss, severe periodontitis has been reported to be a predisposing factor in the development of major systemic diseases such as atherosclerosis, cerebrovascular disease, diabetes, rheumatoid arthritis, Alzheimer's disease and some cancers, and increases the risk of adverse pregnancies (low birth weight, preterm birth). Periodontal inflammation is caused by the presence of gram-negative anaerobic bacteria called "red complex" in the subgingival plaque. Red complex bacteria include Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola, which are responsible for the onset and development of periodontal disease and are found predominantly in the deep periodontal pockets of patients with periodontitis.
In addition, genetic and environmental factors may increase an individual's susceptibility to periodontal disease. The patient's smoking and diabetes mellitus are risk factors for periodontitis. Smoking is the most important environmental risk factor for periodontitis. When subgingival biofilms of nonsmokers/former smokers were compared with smokers, smokers exhibited a higher prevalence of red complex bacteria. Additionally, it has been reported that the potential negative effect of smoking on immune cells, especially neutrophils, makes the individual more susceptible to periodontitis. It has been observed that periodontitis patients who smoke have more alveolar bone and attachment loss than non-smokers. The main goal of periodontal treatment in patients diagnosed with periodontitis is based on removing subgingival biofilm and dental calculus. Before applying surgical periodontal treatment, which is the second step, the first step is non-surgical periodontal treatment and is a prerequisite for deciding to proceed to the surgical stage. In addition to non-surgical periodontal treatment, Local and/or systemic antibiotics, anti-inflammatory drugs, photodynamic therapy, laser, probiotics, prebiotics and synbiotics, statins, ozone therapy, epigenetic therapy, and omega 3-6 can be used. Probiotics modulate the oral microbiota by integrating beneficial bacteria into oral biofilms and preventing the treatment of oral microbial diseases. Probiotics are defined as live microorganisms that provide health benefits when administered in sufficient amounts. The most common probiotic bacteria are Lactobacillus and Bifidobacterium species. Probiotic bifidobacteria have antimicrobial activity against periodontal pathogenic bacteria P. gingivalis and Fusobacterium nucleatum. In an in vitro study by Jasberg et al., it was shown that species belonging to the genus Bifidobacterium could strongly adhere to the subgingival biofilm and significantly reduce the number of Porphyromonas gingivalis. All bifidobacteria integrated well into subgingival biofilms consisting of Porphyromonas gingivalis, Actinomyces naeslundii, and Fusobacterium nucleatum, but only significantly reduced the number of P.gingivalis in biofilms. In the systematic review and meta-analysis evaluating the additional use of probiotics in patients with chronic periodontitis, seven clinical studies evaluating the effectiveness of probiotics as an aid in scaling and root planing were included. While four studies showed additional benefits of probiotics in reducing pocket depth and providing clinical attachment gain, Three studies showed no significant differences. In addition, the difference between the average clinical attachment gain of the patients during the long-term follow-up phases was found to be significant. Today, studies show that probiotic toothpaste effectively prevents infectious diseases such as caries or periodontal disease. However, there are no studies on the effect of smoking on the effectiveness of toothpaste.
Probiotic Toothpaste Content: Glycerin, Hydrated Silica, Aqua, Aloe Barbedensiz, Leaf Juice, Citric Acid, Potassium Sorbate, Sodium Benzoate, Xanthan Gum, B.Coagulans BC4, Xylitol, Sodium Coco-Sulfate, Sodium Hydroxide, Lavandula AngusTifolia (Lavender) Contains Oil (Linalool).
OHIP-14 survey: The effect of the treatment on the patient's quality of life is evaluated with a 14-question survey asked before and one month after non-surgical periodontal treatment.
Periodontal indexes will be taken from all patients in the study group after taking systemic and dental anamnesis. At the first examination session, study samples will be taken, clinical periodontal measurements (plaque index, gingival index, bleeding index, pocket depth, attachment loss, were used to evaluate the periodontal status in 6 regions of each tooth (mesio-buccal, buccal, disto-buccal, disto-palatal, palatal, mesio-palatal) with the Williams periodontal probe (Hu-Friedy, USA) will be measured and recorded) and the oral health effective profile-14 (OHIP-14) questionnaire will be recorded. Afterward, all teeth will be cleaned with an ultrasonic device, and oral hygiene training will be given to the patients. Patients will be taught how to brush their teeth using the modified Bass technique and how to use an interdental brush. In the second session, tooth brushing and interdental brush usage will be checked, and if sufficient, dental floss training will be given; if inadequate, brush usage will be explained again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Using Probiotic ToothpasteUse of probiotic toothpaste + smoking patient |
| Group 2 | No intervention | –Use of regular toothpaste + smoking patient |
| Group 3 | Experimental | Other: Using Probiotic ToothpasteUse of probiotic toothpaste + non-smoking patient |
| Group 4 | No intervention | –Use of regular toothpaste + non-smoking patient |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being over 18 years old
- Pocket depth ≥ 4 mm and clinical attachment loss ≥ 1 mm in at least 5 teeth, bleeding score on probing 20%, and widespread bone loss that can be diagnosed radiographically.
- Absence of any systemic disease
- Having at least 14 natural teeth
- Diagnosing periodontitis as a result of clinical and radiological examinations
Key exclusion criteria (4 listed)
- Being outside the specified age range
- Being pregnant or lactating
- Having used antibiotics for any reason in the last 3 months
- Having had periodontal treatment in the last 6 months
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 |
|---|---|---|
| Using Probiotic ToothpasteScaling and root planing (Phase 1 = non-surgical periodontal treatment) are performed in all patient groups. Depending on the study groups, regular or probiotic toothpaste will be used. Toothpaste is instructed to be used twice a day | Other | Group 1, Group 3 |
Primary outcome
Periodontal pocket depth changes
Time frame: 3 month follow up
Periodontal pocket depth changes will be measured with periodontal probe at baseline and third month postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Yes. If contacted, the principal researcher's evaluation will be shared.
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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.
Berceste Guler Ayyildiz principal investigator
Kutahya Health Science University
Ahu Uraz Corekci principal investigator
Izmir Democracy 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 Using Probiotic Toothpaste in people with Periodontal Diseases and Periodontitis, run by Kutahya Health Sciences 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 6 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: enrolling by invitation, as of the sponsor's last update on 11 Mar 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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 pocket depth changes (time frame: 3 month follow up). 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 11 Mar 2025.