Clinical trial NCT06944938: The Role of Probiotics and Dietary Interventions in the Treatment of Periodontitis
Official title: The Role of Probiotics and Dietary Interventions in the Treatment of Periodontitis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Periodontitis
probiotics
diet
Lead sponsor: Dicle University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Probing Depth (PD) from Baseline to 6 Weeks, measured in millimeters (mm)
timeFrame: Baseline and 6 weeks after intervention
measure: Change in Clinical Attachment Loss (CAL) from Baseline to 6 Weeks, measured in millimeters (mm)
timeFrame: Baseline and 6 weeks after intervention
Secondary outcomes:
measure: Change in Nutrient Intake (Protein, Fiber, Sugar, and Carbohydrate) from Baseline to 6 Weeks
timeFrame: Baseline and week 6
measure: Correlation Between Nutrient Intake and Periodontal Parameters (PD and CAL) at Week 6
timeFrame: Week 6
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Private Dental Clinic, Elazığ, Turkey
state: Diyarbakır
Study officials:
References: