The Effects of Non -Surgical Periodontal Treatment on The Severity of Erectile Dysfunction (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- changes in the severity of Erectile Dysfunction
研究概览
简要总结
The aim of the present study is to study the influence of periodontal therapy (non-surgical) on the severity of erectile dysfunction(ED) among patients with chronic periodontitis and moderate or severe ED.
详细描述
there no sufficient data to determine a possible link between erectile dysfunction ( ED) and periodontitis. Therefore, the purpose of this clinical trial is to study the influence of periodontal therapy (non-surgical) on the severity of ED among patients with chronic periodontitis and moderate or severe ED.
Sample size: The total number of patients in the current trial will be 140 to requite dropout rate during follow-up period.
Patients and study design:
The current trial is a single-blinded, randomized, parallel, controlled clinical study.
The patients with severe or moderate ED will selected from attendants of Andrology Outpatients Clinic, Tanta University Hospital and will referred to Periodontology Department, Tanta University. Statistical software (STATA 13.1, Stata Corp, Texas, USA) will be used on study participants for random allocation that identify to which group the patients will enrolled, using 1:1 allocation ratio.
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
- Single (Participant)
盲法说明
Statistical software (STATA 13.1, Stata Corp, Texas, USA) was used for random and equal stratification of the participants according to their mean values of IIEF, and this identify to which group the patients were enrolled, using 1:1 allocation ratio.
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age from 30 to 40 years
- •Diagnosis with chronic periodontitis using the classification system of (Armitage, 1999)19 for periodontal diseases
- •Presence of at least sixth permanent teeth excluding the third molars20
- •Clinical attachment level (CAL) and pocket depth (PD) ≥4 mm in more than 30% of sites19
- •Severe or moderate ED
- •Male patients
排除标准
- •Alcoholism and smokers
- •Presence of any systemic disorders that may affect ED or periodontal health such as heart disease, diabetes mellitus, and hypertension18
- •Antimicrobial therapies in the last 6 months
- •Periodontal treatment in the last 6 months
- •Drug therapy that may cause ED as side effects such as atenolol and hydrochlorothiazide
研究组 & 干预措施
test group
Non-surgical periodontal treatment consisted of oral hygiene instructions (OHI), single session full-mouth scaling and root planing (SRP)
干预措施: Non surgical periodontal therapy (Procedure)
control group
no periodontal treatment was performed during the follow-up period in the control group.
结局指标
主要结局
changes in the severity of Erectile Dysfunction
时间窗: 3 months
changes in the severity of Erectile Dysfunction diagnosed by International Index of Erectile Dysfunction between test and control groups. Subjects with scores \> 25 were assessed as men with normal sexual function while those with scores ≤ 25 were diagnosed as patients with erectile dysfunction.severe with a score from 6 to 10, moderate (11-16) and mild (17-25)
次要结局
- changes in mean values of TNF-α in serum.Quantitative assessment of TNF-α in serum was done by a commercially available kit (Ray Bio Human TNF-α Enzyme Immunoassay),and was expressed as pg/mL.(3 months)
- changes in mean values of TNF-α in saliva(3 momths)
- changes in mean values of Clinical attachment level(3 months)
研究者
Yasser El Makaky
Associated professor
Taibah University