Impact of Non-surgical Periodontal Therapy on Prostate-specific Antigen Levels and Urinary Tract Infection Recurrence: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in serum prostate-specific antigen (PSA) levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the intervention, blinding of participants and care providers was not feasible.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Antibiotic therapy within the previous 3 months
- •Systemic immunosuppressive disorders
- •History of prostate cancer
- •Ongoing periodontal treatment
- •Severe systemic diseases affecting inflammatory status
研究组 & 干预措施
Control
Participants did not receive periodontal treatment during the 120-day follow-up period.
Non-Surgical Periodontal Therapy
Participants received full-mouth scaling and root planing combined with oral hygiene instruction.
干预措施: Non-surgical periodontal therapy (Procedure)
Oral Hygiene Instruction
Participants received standardized oral hygiene instructions without mechanical periodontal treatment.
干预措施: Oral hygiene instruction (Behavioral)
结局指标
主要结局
Change in serum prostate-specific antigen (PSA) levels
时间窗: Baseline to 120 days
Difference in serum prostate-specific antigen (PSA) levels measured in ng/mL between baseline and 120 days after intervention.
次要结局
- Change in frequency of positive urine cultures(Baseline to 120 days)
研究者
JAVIER MONTERO
Head of Department
University of Salamanca