Skip to main content
OpenTrials
Completed

NCT Number: NCT07438184

Periodontal Therapy and Genitourinary Inflammation in Patients With Prostatitis and Recurrent Urinary Tract Infections

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontitis Chronic Prostatitis (CP) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Mouth Diseases Periodontal Diseases Stomatognathic Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Salamanca

Salamanca, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-surgical periodontal therapy

Procedure

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.

Oral hygiene instruction

Behavioral

Standardized oral hygiene instructions including tooth brushing technique, use of interdental cleaning devices, and reinforcement of plaque control measures, without mechanical periodontal instrumentation.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

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

Acronym: PERIO-PSA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.