Evaluation of the Effect of Systemic Retinoic Acid Use on Micro Ribonucleic Acid (mRNA) Expression in Saliva and Serum
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Pocket probing depth
研究概览
简要总结
Ribonucleic acids (RNA) are molecules that transfer genetic information from the nucleus to the cytoplasm for protein translation. A subgroup of non-coding or non-messenger RNAs, known as microRNAs (miRNAs), regulates the expression of complementary mRNAs without coding for proteins. In this study, the investigators aimed to evaluate the effect of systemically administered oral isotretinoin on gingival health in terms of microRNA (miRNA), a molecule of interest in periodontal research, before, during, and after treatment.
详细描述
Healthy participants (n:25) enrolled for this study. Samples will be collected for each patient at the following time points: immediately before the initiation of retinoic acid treatment, during treatment at week 5 (T1), during treatment at month 5 (T2), and three months after the end of treatment (T3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systemically healthy
- •over 18 and under 45 years of age
- •have at least 20 natural permanent teeth in occlusion excluding third molars,
- •not be pregnant,
- •have not used any antimicrobial and/or anti-inflammatory drugs in the past 3 months,
- •have not received periodontal treatment in the past 6 months,
- •have not undergone surgical periodontal treatment within the past year.
排除标准
- •history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
- •nonsurgical periodontal treatment (previous 6 months)
- •surgical periodontal treatment (previous 12 months)
- •current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
- •pregnancy
研究组 & 干预措施
Experimental
Salivary, serum, miRNA, TNF-a observation Saliva, serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for TNF-a using commercial ELISA kits (Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions.
干预措施: Saliva, serum sampling (Other)
Experimental
Salivary, serum, miRNA, TNF-a observation Saliva, serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for TNF-a using commercial ELISA kits (Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions.
干预措施: oral isotretinoin (Drug)
结局指标
主要结局
Pocket probing depth
时间窗: 6 months
Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Clinical attachment level
时间窗: 6 months
Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ. To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth. In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)
Bleeding on probing
时间窗: 6 months
referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.
次要结局
- Saliva, serum samples processing and analyses(1 month)
研究者
Melis Yilmaz
Assistant Prof Dr
Medipol University