Rapid Maxillary Expansion Related Sutural and Dentoalveolar Changes Provoke Salivary Oxidative Stress: A Biochemical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 主要终点
- Biochemical analyses - 8-OHdG
研究概览
简要总结
The aim of this study was to investigate the effects of rapid maxillary expansion on local and systemic oxidative stress levels. Thirty-five volunteer patients (17 females and 18 males) who needed rapid maxillary expansion will be included in the study. Serum and saliva samples will be collected from each patient during four different periods: a week before the treatment (T0), on the day of sutural separation (T1), at the end of the active expansion period (T2), and after the completion of a 3-month retention period (T3). To evaluate the patients' periodontal status, plaque index, gingival index, and probing pocket depth scores will be recorded for each period. 8-hydroxydeoxyguanosine (8-OHdG), total oxidative status (TOS), total antioxidant capacity (TAS), and oxidative stress index (OSI) biomarkers will be evaluated to determine the local and systemic oxidative stress levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between 11-15 years of age,
- •Having an indication for maxillary expansion due to maxillary stenosis,
- •Being highly cooperative, performing adequate oral care,
- •Being periodontally healthy,
- •Not having cleft lip and/or palate anomalies,
- •Not having any systemic disease,
- •Not having used any medication including antibiotics and anti-inflammatory drugs in the last 6 months,
- •Not being substance addicted and not smoking.
排除标准
- •Having inadequate oral hygiene
- •Being periodontally unhealthy
- •Having cleft lip and/or palate anomalies,
- •Having any systemic disease,
- •Having used any medication including antibiotics and anti-inflammatory drugs in the last 6 months,
- •Being substance addicted and not smoking.
研究组 & 干预措施
T3
The day of completion of the 3-month reinforcement period
干预措施: Rapid maxillary expansion with Hyrax appliance (Procedure)
TO
1 week before the placement of the Hyrax appliance
干预措施: Periodontal measurements (plaque index, gingival index and probing pocket depth scores ) (Other)
TO
1 week before the placement of the Hyrax appliance
干预措施: Biochemical Sample Supply (Collection of serum and saliva samples) (Other)
T1
The day of the first clinical observation of sutural opening (5-7 days after activation)
干预措施: Biochemical Sample Supply (Collection of serum and saliva samples) (Other)
T1
The day of the first clinical observation of sutural opening (5-7 days after activation)
干预措施: Rapid maxillary expansion with Hyrax appliance (Procedure)
T1
The day of the first clinical observation of sutural opening (5-7 days after activation)
干预措施: Periodontal measurements (plaque index, gingival index and probing pocket depth scores ) (Other)
T2
The day of completion of active expansion (3-4 weeks)
干预措施: Periodontal measurements (plaque index, gingival index and probing pocket depth scores ) (Other)
T2
The day of completion of active expansion (3-4 weeks)
干预措施: Biochemical Sample Supply (Collection of serum and saliva samples) (Other)
T2
The day of completion of active expansion (3-4 weeks)
干预措施: Rapid maxillary expansion with Hyrax appliance (Procedure)
T3
The day of completion of the 3-month reinforcement period
干预措施: Biochemical Sample Supply (Collection of serum and saliva samples) (Other)
T3
The day of completion of the 3-month reinforcement period
干预措施: Periodontal measurements (plaque index, gingival index and probing pocket depth scores ) (Other)
结局指标
主要结局
Biochemical analyses - 8-OHdG
时间窗: a week before the treatment (T0), 5-7 days after activation (T1), 3rd week (T2), and after the completion of a 3-month retention period (T3)
8-OHdG is the most frequently encountered and best known mutagenicity of more than 20 oxidative base damage products of ROS in DNA. Since it is easily detected in living cells and body fluids, it is the most commonly used oxidative DNA damage marker. Serum and saliva levels will be measured using a suitable ELISA kit (Cayman Chemical DNA/RNA Oxidative Damage ELISA Kit Item No.589320) according to the manufacturer's instructions. The measurement principle is as follows: It is based on the competition between 8-OHdG from the sample and 8-OHdG-acetylcholinestarase conjugate (8- OHdG Tracer) from the kit for a limited amount of 8-OHdG monoclonal antibody covering the plate well. The colour intensity measured spectrophotometrically at 410 nm is directly proportional to the tracer and inversely proportional to the amount of free 8-OHdG in the sample.
Biochemical analyses - Oxidative Stress Index (TOS/TAS=OSI)
时间窗: a week before the treatment (T0), 5-7 days after activation (T1), 3rd week (T2), and after the completion of a 3-month retention period (T3)
Total Oxidative Status (TOS) is a current method used to detect lipid peroxidation and oxidative stress. TOS is considered to be a superior method compared to other methods due to the impracticality of measuring different oxidant molecules individually and the inability to fully reflect the interaction of oxidant molecules with each other. Total Antioxidan Status (TAS) is a biochemical parameter obtained as a result of the sum of the antioxidant capacities of all antioxidants in the biological samples examined. Oxidative Stress Index (OSI) is a proportional value obtained by dividing TOS by TAS. It is directly affected by total oxidative and antioxidant status and reveals the final oxidative status in a practical and understandable way. OSI value was calculated according to the following formula. OSI = TOS (mmol H2O2 Equiv./L) / TAS (mmol Trolox Equiv./L) x 100
次要结局
- Clinical Periodontal Assessments-plaque index(a week before the treatment (T0), 5-7 days after activation (T1), 3rd week (T2), and after the completion of a 3-month retention period (T3))
- Clinical Periodontal Assessments-gingival index(a week before the treatment (T0), 5-7 days after activation (T1), 3rd week (T2), and after the completion of a 3-month retention period (T3))
- Clinical Periodontal Assessments-probed pocket depth (PPD)(a week before the treatment (T0), 5-7 days after activation (T1), 3rd week (T2), and after the completion of a 3-month retention period (T3))
研究者
Dilek KARADOĞAN
Assoc. Prof. Dr.
Recep Tayyip Erdogan University Training and Research Hospital