PeriodontitisPERIO-PSANCT07438184
Periodontal Therapy and Genitourinary Inflammation in Patients With Prostatitis and Recurrent Urinary Tract Infections
A study testing Non-surgical periodontal therapy and Oral hygiene instruction in people with Periodontitis and Chronic Prostatitis (CP), run by University of Salamanca at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Periodontitis, Chronic Prostatitis (CP), Urinary Tract Infections
- What is being tested?
- Non-surgical periodontal therapy and Oral hygiene instruction
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Antibiotic therapy within the previous 3 months
- Systemic immunosuppressive disorders
- History of prostate cancer
- Ongoing periodontal treatment
- Severe systemic diseases affecting inflammatory status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Non-surgical periodontal therapy, Oral hygiene instruction
- Medical subject headings
- Periodontitis, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal therapyProcedure or surgery
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 instructionBehavioural
Standardized oral hygiene instructions including tooth brushing technique, use of interdental cleaning devices, and reinforcement of plaque control measures, without mechanical periodontal instrumentation.
| Study group | Role | What they receive |
|---|---|---|
| Non-Surgical Periodontal Therapy | Experimental | Participants received full-mouth scaling and root planing combined with oral hygiene instruction. Receives: Procedure: Non-surgical periodontal therapy |
| Oral Hygiene Instruction | Active comparator | Participants received standardized oral hygiene instructions without mechanical periodontal treatment. Receives: Behavioral: Oral hygiene instruction |
| Control | No intervention | Participants did not receive periodontal treatment during the 120-day follow-up period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 120 days
Secondary outcomes (1)
Change in frequency of positive urine cultures
Difference in the number of microbiologically confirmed urinary tract infections between baseline and 120 days.
Measured: Baseline to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jan 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER MONTERO, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438184
- Sponsor's protocol ID
- PTPSA24
- Other IDs
- 2021/10/889
- Acronym
- PERIO-PSA
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-surgical Periodontal Therapy on Prostate-specific Antigen Levels and Urinary Tract Infection Recurrence: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07438184
- Acronym / sponsor ID
- PERIO-PSA / PTPSA24
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-Surgical Periodontal Therapy | Experimental | Procedure: Non-surgical periodontal therapyParticipants received full-mouth scaling and root planing combined with oral hygiene instruction. |
| Oral Hygiene Instruction | Active comparator | Behavioral: Oral hygiene instructionParticipants received standardized oral hygiene instructions without mechanical periodontal treatment. |
| Control | No intervention | –Participants did not receive periodontal treatment during the 120-day follow-up period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Antibiotic therapy within the previous 3 months
- Systemic immunosuppressive disorders
- History of prostate cancer
- Ongoing periodontal treatment
- Severe systemic diseases affecting inflammatory status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical periodontal therapyFull-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. | Procedure or surgery | Non-Surgical Periodontal Therapy |
| Oral hygiene instructionStandardized oral hygiene instructions including tooth brushing technique, use of interdental cleaning devices, and reinforcement of plaque control measures, without mechanical periodontal instrumentation. | Behavioural | Oral Hygiene Instruction |
Primary outcome
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.
1 secondary outcome
Change in frequency of positive urine cultures
Time frame: Baseline to 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal therapy and Oral hygiene instruction in people with Periodontitis and Chronic Prostatitis (CP), run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum prostate-specific antigen (PSA) levels (time frame: Baseline to 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.