Periodontal Therapy and Genitourinary Inflammation in Patients With Prostatitis and Recurrent Urinary Tract Infections (PERIO-PSA)

March 10, 2026 updated by: JAVIER MONTERO, University of Salamanca

Impact of Non-surgical Periodontal Therapy on Prostate-specific Antigen Levels and Urinary Tract Infection Recurrence: a Randomized Controlled Clinical Trial

This randomized controlled clinical trial evaluates the impact of non-surgical periodontal therapy on systemic inflammatory markers in patients with chronic prostatitis or recurrent urinary tract infections. Emerging evidence suggests a possible association between periodontal inflammation and genitourinary conditions.

A total of 60 male participants diagnosed with periodontitis and either chronic prostatitis or recurrent urinary tract infections were randomly assigned to one of three groups: non-surgical periodontal therapy, oral hygiene instruction only, or no periodontal treatment. The primary outcomes were changes in serum prostate-specific antigen (PSA) levels and the frequency of positive urine cultures over a 120-day follow-up period.

The study aims to investigate whether periodontal treatment may reduce systemic inflammatory burden and improve genitourinary clinical parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This parallel-group randomized clinical trial was conducted at a university healthcare center. Eligible participants were adult male patients diagnosed with periodontitis and chronic prostatitis (NIH category III) or recurrent urinary tract infections.

Participants were randomly allocated to receive full-mouth scaling and root planing combined with oral hygiene instruction, oral hygiene instruction alone, or no periodontal intervention during the study period.

Clinical periodontal parameters, serum PSA levels, and microbiological urine cultures were assessed at baseline and at 120 days. Statistical analyses were performed to evaluate intergroup differences and longitudinal changes.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain
        • University of Salamanca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male participants aged 18 years or older
  • Diagnosis of chronic prostatitis (NIH category III) or recurrent urinary tract infections
  • Diagnosis of periodontitis according to the 2017 World Workshop classification
  • Ability to provide written informed consent

Exclusion Criteria:

  • Antibiotic therapy within the previous 3 months
  • Systemic immunosuppressive disorders
  • History of prostate cancer
  • Ongoing periodontal treatment

Severe systemic diseases affecting inflammatory status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Surgical Periodontal Therapy
Participants received full-mouth scaling and root planing combined with oral hygiene instruction.
Procedure: Non-surgical periodontal therapy
Full-mouth scaling and root planing performed under local anesthesia using ultrasonic and hand instruments, completed within two sessions over a one-week period. Participants also received standardized oral hygiene instructions including tooth brushing technique and interdental cleaning guidance.
Active Comparator: Oral Hygiene Instruction
Participants received standardized oral hygiene instructions without mechanical periodontal treatment.
Behavioral: Oral hygiene instruction
Standardized oral hygiene instructions including tooth brushing technique, use of interdental cleaning devices, and reinforcement of plaque control measures, without mechanical periodontal instrumentation.
No Intervention: Control
Participants did not receive periodontal treatment during the 120-day follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum prostate-specific antigen (PSA) levels
Time Frame: Baseline to 120 days
Difference in serum prostate-specific antigen (PSA) levels measured in ng/mL between baseline and 120 days after intervention.
Baseline to 120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in frequency of positive urine cultures
Time Frame: Baseline to 120 days
Difference in the number of microbiologically confirmed urinary tract infections between baseline and 120 days.
Baseline to 120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTPSA24
  • 2021/10/889 (Other Identifier: University of Salamanca)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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