Effect of non-surgical periodontal therapy among men diagnosed with infertility - A Randomized controlled clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- The effect of non-surgical periodontal therapy in men with male factor infertility will be evaluated by assessing the change in biochemical,andrological and clinical parameters.
研究概览
简要总结
This study is a randomized,parallel group,prospective design .Male patients visiting the department of Urology KMC Manipal, diagnosed with male factor infertility (MFI), As per the assesment by andrological parameters like sperm cell (concentration, motility, morphology) and these patients will be considered as the potential participants in this trial. The subjects will undergo oral examination and those matching the inclusion criteria will be included in this study. The subjects voluntarily willing to participate will be explained about the details of the study and an informed consent will be obtained. Following which the patients will be randomly allocated into two groups. Randomization will be done using block randomization with a block size of 4 samples with an allocation ratio of 1:1. Randomization will be done manually by using sequentially numbered opaque envelopes for treatment allocation into 9 blocks with each block containing 4 codes of samples. All patients will receive the standard therapy for infertility as per the protocol of department of urology. Group 1 Treatment group (TG) and Group 2 control group (CG) will be based on the periodontal non- surgical therapeutic intervention or only oral hygiene instructions. For every patient detailed case history and periodontal parameters - Plaque index (Silness&Loe1964), Gingival index (Loe&Silness1963), Periodontal Probing Depth (PPD), Clinical Attachment Level (CAL) will be charted on a standard proforma. Additional investigation will involve analysis of salivary biomarker level (IL-1β) and antioxidant (Thiol) two ml of unstimulated saliva will be collected by asking the patient to sit in coachman’s position. Sample will be collected in Eppendorf tubes and refrigerate at -800c till further examination. Semen samples collected from the participants will be used for examining the biomarker levels of IL- 1ẞ and Thiol.
In treatment group (TG), patients will be receiving scaling and/ or root planing depending on the periodontal status i.e. Gingivitis and/or Periodontitis along with oral hygiene instructions.
In control group (CG), patients will be given only oral hygiene instructions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male patients diagnosed with infertility Diagnosed with gingivitis or periodontitis Devoid of oral infections/diseases Patients who are systemically healthy Patients having grade I and II variocele.
排除标准
- •Family history of infertility History of periodontal therapy within 3 months Exposure to antibiotics within preceeding 6 months Patients with azoospermia Consumption of alcohol or smoking Patients having testicular abnormalities.
结局指标
主要结局
The effect of non-surgical periodontal therapy in men with male factor infertility will be evaluated by assessing the change in biochemical,andrological and clinical parameters.
时间窗: Baseline,3 months
次要结局
- By the result of primary outcome,patients will understand the link between oral health and systemic conditions and this awarness will help the patients maintaining their oral health