Gingival Crevicular Fluid Levels of Prolactin Hormone in Type 2 Diabetic Patients With Stage III Periodontitis Before and After Non-Surgical Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Prolactin Hormone Levels in Gingival Crevicular Fluid
研究概览
简要总结
evaluate the role of prolactin hormone in the pathogenesis of periodontitis by assessing its local gingival levels and assess clinical parameters in patients who have type two diabetes
详细描述
Periodontal Examination At baseline, all participants received a full-mouth clinical examination, and the following periodontal parameters will be recorded: Plaque Index (PI) (19), Gingival Index (GI) (20), Pocket Depth (PD), and Clinical Attachment Loss (CAL).
Initial periodontal examination, full mouth scaling and root planning (SRP), clinical measurements before and after treatment, gingival crevicular fluid sampling as well as reinforcement of oral hygiene at baseline and during follow-up evaluations will be performed by the same periodontist (E.A.). Reinforcement of oral hygiene will be done every month for 3 months.
Gingival fluid sampling:
Gingival crevicular fluid (GCF) collection will be done the second day after clinical examination to prevent the contamination of sample with blood associated with the probing of inflamed sites. Samples will be collected from the buccal aspects of two interproximal sites in teeth that had the highest signs of inflammation and attachment loss for periodontitis groups, this will be done before, and 3 months after SRP. For the control group, samples will be collected from the upper first molar.
The samples will be assayed for PRL by using an enzyme linked immunosorbent assay (ELISA) kits.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range from 18 to 60 years
- •Stage III periodontitis
- •Type 2 diabetes
- •Only patients signing informed written consents
排除标准
- •Pregnancy or lactation
- •Any known systemic disease
- •Any type of previous periodontal treatment (surgical or non-surgical) in the preceding 6 months
- •Smoking (former or current)
结局指标
主要结局
Change in Prolactin Hormone Levels in Gingival Crevicular Fluid
时间窗: Baseline and 3 months after non-surgical periodontal treatment
Gingival crevicular fluid (GCF) will be collected to measure prolactin hormone levels using enzyme-linked immunosorbent assay (ELISA) kits. Samples will be taken from the buccal aspects of two interproximal sites in each participant. Baseline and post-treatment samples will be collected and analyzed. Higher prolactin levels may be associated with more severe inflammation. Unit of Measure :ng/mL
次要结局
- Change in Plaque Index (PI)(Baseline and 3 months after treatment)
- Change in Gingival Index (GI)(Baseline and 3 months after treatment)
- Change in Probing Depth (PD)(Baseline and 3 months after treatment)
- Change in Clinical Attachment Level (CAL)(Baseline and 3 months after treatment)
研究者
Sara Ibrahim
master's degree student at oral medicine, peridontology ,oral diagnosis and oral Radiology Department, faculty of Dental Medicine for Girls ,Al Azhar university
Faculty of Dental Medicine for Girls