Periodontal DiseasesNCT06944938
The Role of Probiotics and Dietary Interventions in the Treatment of Periodontitis
A study testing Non-Surgical Periodontal Treatment, Probiotic Supplementation and Probiotic Supplementation + Personalized Diet in people with Periodontal Diseases, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of probiotic supplementation and diet-supported probiotic use on periodontal clinical parameters in individuals with periodontitis. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Non-Surgical Periodontal Treatment, Probiotic Supplementation and Probiotic Supplementation + Personalized Diet
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Oct 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged between 20 and 60 years Clinical diagnosis of periodontitis Presence of at least 20 natural teeth Probing depth between 3 mm and 7 mm (mild to moderate periodontitis) No history of systemic diseases Willingness to participate and provide written informed consent
Who cannot join
- Use of antibiotics or probiotics within the past 6 months Current pregnancy or lactation Smoking Presence of systemic conditions such as diabetes or cardiovascular disease Fewer than 20 natural teeth Inability or unwillingness to comply with study procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Dental Clinic, Elazığ, Turkey
Elazığ, Diyarbakır, 21280
About this study
Official title: The Role of Probiotics and Dietary Interventions in the Treatment of Periodontitis: A Randomized Controlled Clinical Trial
The aim of this study is to evaluate the effects of probiotic supplementation and diet-supported probiotic use on periodontal clinical parameters in individuals with periodontitis. A total of 120 female participants aged between 20-60 years, diagnosed with periodontitis and without systemic diseases, were included in the study. Participants are randomly assigned into three groups: a control group (conventional treatment), a probiotic group (conventional treatment + probiotics), and a diet + probiotic group (conventional treatment + probiotics + personalized diet). Clinical evaluations are performed using measurements of probing depth (PD) and clinical attachment loss (CAL), while dietary intake is assessed using three-day food records. The collected data will be analyzed using SPSS 21.0 software, and a p-value <0.05 will be considered statistically significant.
Read the detailed description
Periodontitis is a chronic inflammatory disease that results in the destruction of the supporting tissues of the teeth, potentially leading to tooth loss if left untreated. While conventional periodontal treatment focuses on mechanical removal of plaque and calculus, there is increasing interest in adjunctive therapies that target the host response and the oral microbiome.
Probiotic supplementation has been suggested as a potential supportive approach in periodontal therapy, owing to its ability to modulate the microbial balance and reduce inflammation. Moreover, dietary habits-especially the intake of protein, fiber, sugar, and carbohydrates-may influence periodontal health by affecting systemic and local inflammatory responses.
This randomized controlled clinical trial investigates the effects of probiotic supplementation and a personalized anti-inflammatory diet in individuals with periodontitis. A total of 120 female participants aged 20 to 60 years, without systemic diseases, are included. The participants are randomly assigned into three parallel groups:
Control group: conventional non-surgical periodontal treatment
Probiotic group: conventional treatment + probiotic supplementation
Diet + probiotic group: conventional treatment + probiotic supplementation + personalized diet counseling
The intervention period lasts six weeks. Clinical periodontal parameters, including probing depth (PD) and clinical attachment loss (CAL), are assessed at baseline and at the end of the study. Dietary intake is evaluated through three-day food records collected before and after the intervention.
This study aims to explore the potential of integrating probiotics and diet modifications into a holistic periodontal treatment model. Results will be analyzed following data collection and are not included in this section.
- Conditions
- Periodontal Diseases
- Being tested
- Non-Surgical Periodontal Treatment, Probiotic Supplementation, Probiotic Supplementation + Personalized Diet
- Keywords
- Periodontitis, probiotics, diet
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Periodontal TreatmentProcedure or surgery
Participants in this arm received standard non-surgical periodontal treatment, including scaling and root planing, without any additional supplementation or dietary modification.
Probiotic SupplementationDietary supplement
Participants in this arm received standard periodontal treatment along with a daily probiotic supplement (1 capsule/day, containing 10⁹ CFU of Lactobacillus rhamnosus and Bifidobacterium animalis subsp. lactis) for six consecutive weeks.
Probiotic Supplementation + Personalized DietOther
Participants in this arm received standard periodontal treatment, the same probiotic protocol as the probiotic group, and a personalized anti-inflammatory diet. The diet was developed by a clinical dietitian and emphasized high-fiber, antioxidant-rich, and prebiotic foods. Consumption of refined carbohydrates, added sugars, and trans fats was restricted.
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | traditional periodontitis treatment Receives: Procedure: Non-Surgical Periodontal Treatment |
| Probiotic group | Experimental | traditional periodontitis treatment + probiotic support Receives: Procedure: Non-Surgical Periodontal Treatment; Dietary Supplement: Probiotic Supplementation |
| Probiotic+diet group | Experimental | traditional periodontitis treatment + probiotic support + diet Receives: Procedure: Non-Surgical Periodontal Treatment; Dietary Supplement: Probiotic Supplementation; Other: Probiotic Supplementation + Personalized Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Depth (PD) from Baseline to 6 Weeks, measured in millimeters (mm)
Probing depth will be measured at six sites per tooth using a UNC-15 periodontal probe. The mean PD per participant will be calculated, and group-level data will be reported as mean ± standard deviation (SD). PD represents the distance from the gingival margin to the base of the periodontal pocket.
Measured: Baseline and 6 weeks after intervention
Change in Clinical Attachment Loss (CAL) from Baseline to 6 Weeks, measured in millimeters (mm)
Clinical attachment loss (CAL) will be assessed at six sites per tooth using a UNC-15 periodontal probe. CAL is defined as the distance from the cemento-enamel junction (CEJ) to the bottom of the pocket. The average CAL per participant will be calculated and presented as mean ± SD at the group level.
Measured: Baseline and 6 weeks after intervention
Secondary outcomes (2)
Change in Nutrient Intake (Protein, Fiber, Sugar, and Carbohydrate) from Baseline to 6 Weeks
Three-day food records will be collected at baseline and at week 6. Nutrient intake will be analyzed for protein, fiber, sugar, and carbohydrate using validated dietary analysis software. Data will be reported as mean intake (g/day) and compared across groups.
Measured: Baseline and week 6
Correlation Between Nutrient Intake and Periodontal Parameters (PD and CAL) at Week 6
Pearson correlation analysis will be conducted to examine the relationship between dietary intake (fiber, protein, sugar, carbohydrate) and clinical periodontal outcomes (PD and CAL) at 6 weeks. Results will be reported as correlation coefficients (r) with p-values.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Oct 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feray ÇAĞIRAN YILMAZ, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944938
- Sponsor's protocol ID
- Dicle University Nutrition
- Status last verified
- Oct 2019
- First submitted
- 10 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with those who request it.
Publications
Yilmaz FC, Gorgin NC. The role of probiotics and dietary interventions in the treatment of periodontitis: a pilot randomized controlled clinical trial. BMC Oral Health. 2025 Jul 31;25(1):1287. doi: 10.1186/s12903-025-06510-4.
PubMed 40745652
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Probiotics and Dietary Interventions in the Treatment of Periodontitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06944938
- Acronym / sponsor ID
- Dicle University Nutrition
- Conditions
- Periodontal Diseases
- Keywords
- Periodontitis, probiotics, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 25 Apr 2025 (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.
The aim of this study is to evaluate the effects of probiotic supplementation and diet-supported probiotic use on periodontal clinical parameters in individuals with periodontitis. A total of 120 female participants aged between 20-60 years, diagnosed with periodontitis and without systemic diseases, were included in the study. Participants are randomly assigned into three groups: a control group (conventional treatment), a probiotic group (conventional treatment + probiotics), and a diet + probiotic group (conventional treatment + probiotics + personalized diet). Clinical evaluations are performed using measurements of probing depth (PD) and clinical attachment loss (CAL), while dietary intake is assessed using three-day food records. The collected data will be analyzed using SPSS 21.0 software, and a p-value <0.05 will be considered statistically significant.
Detailed description
Periodontitis is a chronic inflammatory disease that results in the destruction of the supporting tissues of the teeth, potentially leading to tooth loss if left untreated. While conventional periodontal treatment focuses on mechanical removal of plaque and calculus, there is increasing interest in adjunctive therapies that target the host response and the oral microbiome.
Probiotic supplementation has been suggested as a potential supportive approach in periodontal therapy, owing to its ability to modulate the microbial balance and reduce inflammation. Moreover, dietary habits-especially the intake of protein, fiber, sugar, and carbohydrates-may influence periodontal health by affecting systemic and local inflammatory responses.
This randomized controlled clinical trial investigates the effects of probiotic supplementation and a personalized anti-inflammatory diet in individuals with periodontitis. A total of 120 female participants aged 20 to 60 years, without systemic diseases, are included. The participants are randomly assigned into three parallel groups:
Control group: conventional non-surgical periodontal treatment
Probiotic group: conventional treatment + probiotic supplementation
Diet + probiotic group: conventional treatment + probiotic supplementation + personalized diet counseling
The intervention period lasts six weeks. Clinical periodontal parameters, including probing depth (PD) and clinical attachment loss (CAL), are assessed at baseline and at the end of the study. Dietary intake is evaluated through three-day food records collected before and after the intervention.
This study aims to explore the potential of integrating probiotics and diet modifications into a holistic periodontal treatment model. Results will be analyzed following data collection and are not included in this section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Procedure: Non-Surgical Periodontal Treatmenttraditional periodontitis treatment |
| Probiotic group | Experimental | Procedure: Non-Surgical Periodontal Treatment, Dietary Supplement: Probiotic Supplementationtraditional periodontitis treatment + probiotic support |
| Probiotic+diet group | Experimental | Procedure: Non-Surgical Periodontal Treatment, Dietary Supplement: Probiotic Supplementation, Other: Probiotic Supplementation + Personalized Diettraditional periodontitis treatment + probiotic support + diet |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female participants aged between 20 and 60 years Clinical diagnosis of periodontitis Presence of at least 20 natural teeth Probing depth between 3 mm and 7 mm (mild to moderate periodontitis) No history of systemic diseases Willingness to participate and provide written informed consent
Key exclusion criteria (1 listed)
- Use of antibiotics or probiotics within the past 6 months Current pregnancy or lactation Smoking Presence of systemic conditions such as diabetes or cardiovascular disease Fewer than 20 natural teeth Inability or unwillingness to comply with study procedures
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 |
|---|---|---|
| Non-Surgical Periodontal TreatmentParticipants in this arm received standard non-surgical periodontal treatment, including scaling and root planing, without any additional supplementation or dietary modification. | Procedure or surgery | Probiotic group, Probiotic+diet group, control group |
| Probiotic SupplementationParticipants in this arm received standard periodontal treatment along with a daily probiotic supplement (1 capsule/day, containing 10⁹ CFU of Lactobacillus rhamnosus and Bifidobacterium animalis subsp. lactis) for six consecutive weeks. | Dietary supplement | Probiotic group, Probiotic+diet group |
| Probiotic Supplementation + Personalized DietParticipants in this arm received standard periodontal treatment, the same probiotic protocol as the probiotic group, and a personalized anti-inflammatory diet. The diet was developed by a clinical dietitian and emphasized high-fiber, antioxidant-rich, and prebiotic foods. Consumption of refined carbohydrates, added sugars, and trans fats was restricted. | Other | Probiotic+diet group |
Primary outcome
Change in Probing Depth (PD) from Baseline to 6 Weeks, measured in millimeters (mm)
Time frame: Baseline and 6 weeks after intervention
Probing depth will be measured at six sites per tooth using a UNC-15 periodontal probe. The mean PD per participant will be calculated, and group-level data will be reported as mean ± standard deviation (SD). PD represents the distance from the gingival margin to the base of the periodontal pocket.
Change in Clinical Attachment Loss (CAL) from Baseline to 6 Weeks, measured in millimeters (mm)
Time frame: Baseline and 6 weeks after intervention
Clinical attachment loss (CAL) will be assessed at six sites per tooth using a UNC-15 periodontal probe. CAL is defined as the distance from the cemento-enamel junction (CEJ) to the bottom of the pocket. The average CAL per participant will be calculated and presented as mean ± SD at the group level.
2 secondary outcomes
Change in Nutrient Intake (Protein, Fiber, Sugar, and Carbohydrate) from Baseline to 6 Weeks
Time frame: Baseline and week 6
Correlation Between Nutrient Intake and Periodontal Parameters (PD and CAL) at Week 6
Time frame: Week 6
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 25 Apr 2025.
- Derived from this study: PubMed 40745652Yilmaz FC, Gorgin NC. The role of probiotics and dietary interventions in the treatment of periodontitis: a pilot randomized controlled clinical trial. BMC Oral Health. 2025 Jul 31;25(1):1287. doi: 10.1186/s12903-025-06510-4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be shared with those who request it.
Related trials for Periodontal Diseases
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
Antibiotic Resistance Genes in Periodontitis
Periodontal Disease, Periodontitis
RecruitingObservational study
Candida Albicans in Syrian Patients With Periodontitis
Periodontal Disease, Periodontal Diseases
Recruiting
Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life
Periodontitis, Periodontal Diseases
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Periodontal Treatment, Probiotic Supplementation and Probiotic Supplementation + Personalized Diet in people with Periodontal Diseases, run by Dicle 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 1 inclusion and 1 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 25 Apr 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?
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?
Change in Probing Depth (PD) from Baseline to 6 Weeks, measured in millimeters (mm) (time frame: Baseline and 6 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06944938, which also lists 1 linked publication.
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 25 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.