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临床试验/CTRI/2023/01/048742
CTRI/2023/01/048742尚未招募不适用

Evaluation and comparison of levels of matrix metalloproteinase-8, osteocalcin and alkaline phosphatase in gingival crevicular fluid at different stages of orthodontic treatment: An in-vivo study

Rony T Kondody1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
1.levels of Matrix Metalloproteinase-8, Osteocalcin, and alkaline

研究概览

简要总结

The orthodontic tooth movement is a complex mechanism, that involves interactions between various cells of the periodontal ligament, and alveolar bone, as well as multiple intercellular actions. These forces of tooth movement produce an environment that is described as a continuous sequence of inflammation and repair designed to restore normal tissue continuity and function. The mechanisms responsible for converting orthodontic force into cellular responses, including cellular differentiation, at present, remain an area of ambiguity. It has been observed that markers of bone remodeling are found in GCF. Therefore, it has been shown that GCF may reflect the immune and inflammatory reactions arising from the application of orthodontic force. While studying the levels of biomarkers in the GCF of patients undergoing OTM, one of the main drawbacks observed in orthodontics was the longer duration of orthodontic treatment as they pose various disadvantages such as root resorption, gingival inflammation, enamel decalcification, etc. Accelerated orthodontics has gained popularity in recent years and it has been proposed to accelerate orthodontic tooth movement. Further, studies regarding the levels of various biomarkers in the human GCF at the various stages of orthodontic treatment like the initial phase of levelling and alignment, the initial stages of space close and debonding phase, and their association with clinical outcomes. Therefore the purpose of this study is to evaluate levels of matrix metalloproteinase-8, osteocalcin, and alkaline phosphatase in gingival crevicular fluid at different stages of orthodontic treatment

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 22.00 Year(s)(—)
性别
All

入选标准

  • The inclusion criteria will include, patients requiring first premolar extraction cases, cases which belong to Angles’ Class I bimaxillary, Class II Div 1 malocclusion (ANB ≤ 5degree), mandibular incisor irregularity of 4–6 mm, good oral conditions with no bleeding on probing and also with no radiographic evidence of periodontal bone loss after the radiographic periapical examination.

排除标准

  • Patients who are taking various anti-inflammatory drugs, also patients with various local and general systemic conditions which could influence the levels of biomarkers.

结局指标

主要结局

1.levels of Matrix Metalloproteinase-8, Osteocalcin, and alkaline

时间窗: 4 years

phosphatase in GCF during the initial leveling and alignment stage by using two different

时间窗: 4 years

2. levels of Matrix Metalloproteinase-8, Osteocalcin, and alkaline

时间窗: 4 years

archwires.

时间窗: 4 years

using the split-mouth design.

时间窗: 4 years

3. To compare rate of retraction between the conventional and micro

时间窗: 4 years

phosphatase in GCF during initial space closure with and without micro-osteoperforation

时间窗: 4 years

osteoperforation groups in the digital model using the split-mouth design.

时间窗: 4 years

4. Compare the levels of Matrix Metalloproteinase-8, Osteocalcin, and alkaline

时间窗: 4 years

phosphatase in GCF at debonding stage and after 6 months of the retention period.

时间窗: 4 years

次要结局

  • Evaluate levels of matrix metalloproteinase-8, osteocalcin, and alkaline phosphatase in gingival crevicular fluid at different stages of orthodontic treatment(4 years)

研究者

发起方
Rony T Kondody
申办方类型
Other [Self sponsored]

研究点 (1)

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