NCT06944938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
Last Updated

April 25, 2025

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

April 10, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

Periodontitisprobioticsdiet

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and 6 weeks after intervention

Secondary Outcomes (2)

  • Change in Nutrient Intake (Protein, Fiber, Sugar, and Carbohydrate) from Baseline to 6 Weeks

    Baseline and week 6

  • Correlation Between Nutrient Intake and Periodontal Parameters (PD and CAL) at Week 6

    Week 6

Study Arms (3)

control group

EXPERIMENTAL

traditional periodontitis treatment

Procedure: Non-Surgical Periodontal Treatment

Probiotic group

EXPERIMENTAL

traditional periodontitis treatment + probiotic support

Procedure: Non-Surgical Periodontal TreatmentDietary Supplement: Probiotic Supplementation

Probiotic+diet group

EXPERIMENTAL

traditional periodontitis treatment + probiotic support + diet

Procedure: Non-Surgical Periodontal TreatmentDietary Supplement: Probiotic SupplementationOther: Probiotic Supplementation + Personalized Diet

Interventions

Participants in this arm received standard non-surgical periodontal treatment, including scaling and root planing, without any additional supplementation or dietary modification.

Probiotic groupProbiotic+diet groupcontrol group
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 groupProbiotic+diet group

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.

Probiotic+diet group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Dental Clinic, Elazığ, Turkey

Elazığ, Diyarbakır, 21280, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 25, 2025

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

April 25, 2025

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Data will be shared with those who request it.

Locations