- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06944938
The Role of Probiotics and Dietary Interventions in the Treatment of Periodontitis
The Role of Probiotics and Dietary Interventions in the Treatment of Periodontitis: A Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Diyarbakır
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Elazığ, Diyarbakır, Turkey, 21280
- Private Dental Clinic, Elazığ, Turkey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: control group
traditional periodontitis treatment
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Participants in this arm received standard non-surgical periodontal treatment, including scaling and root planing, without any additional supplementation or dietary modification.
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Experimental: Probiotic group
traditional periodontitis treatment + probiotic support
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Participants in this arm received standard non-surgical periodontal treatment, including scaling and root planing, without any additional supplementation or dietary modification.
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.
|
|
Experimental: Probiotic+diet group
traditional periodontitis treatment + probiotic support + diet
|
Participants in this arm received standard non-surgical periodontal treatment, including scaling and root planing, without any additional supplementation or dietary modification.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Probing Depth (PD) from Baseline to 6 Weeks, measured in millimeters (mm)
Time Frame: Baseline and 6 weeks after intervention
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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.
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Baseline and 6 weeks after intervention
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Change in Clinical Attachment Loss (CAL) from Baseline to 6 Weeks, measured in millimeters (mm)
Time Frame: Baseline and 6 weeks after intervention
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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.
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Baseline and 6 weeks after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Nutrient Intake (Protein, Fiber, Sugar, and Carbohydrate) from Baseline to 6 Weeks
Time Frame: Baseline and week 6
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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.
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Baseline and week 6
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Correlation Between Nutrient Intake and Periodontal Parameters (PD and CAL) at Week 6
Time Frame: Week 6
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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.
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Week 6
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dicle University Nutrition
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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