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

NCT07438184 | Completed

• 2 other identifiers: PTPSA242021/10/889
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis; Chronic Prostatitis (CP); Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Change in serum prostate-specific antigen (PSA) levels

  Difference in serum prostate-specific antigen (PSA) levels measured in ng/mL between baseline and 120 days after intervention.

  Baseline to 120 days

Secondary Outcomes (1)

• Change in frequency of positive urine cultures

  Baseline to 120 days

Study Arms (3)

Non-Surgical Periodontal Therapy

EXPERIMENTAL

Participants received full-mouth scaling and root planing combined with oral hygiene instruction.

Procedure: Non-surgical periodontal therapy

Oral Hygiene Instruction

ACTIVE COMPARATOR

Participants received standardized oral hygiene instructions without mechanical periodontal treatment.

Behavioral: Oral hygiene instruction

Control

NO INTERVENTION

Participants did not receive periodontal treatment during the 120-day follow-up period.

Interventions

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.

Non-Surgical Periodontal Therapy

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.

Oral Hygiene Instruction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Antibiotic therapy within the previous 3 months
• Systemic immunosuppressive disorders
• History of prostate cancer
• Ongoing periodontal treatment
• Severe systemic diseases affecting inflammatory status

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, Spain

Location

MeSH Terms

Conditions

Periodontitis; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, blinding of participants and care providers was not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Model Details: Participants were randomly assigned in a parallel design to one of three groups: non-surgical periodontal therapy, oral hygiene instruction, or no periodontal treatment, with a 120-day follow-up period.

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: January 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)