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临床试验/CTRI/2024/12/078161
CTRI/2024/12/078161尚未招募不适用

QUANTITATIVE ANALYSIS OF INTERLEUKIN- 6 IN GINGIVAL CREVICULAR FLUID: A COMPARATIVE CLINICAL STUDY OF ONE WEEK VERSUS TWO WEEK ALIGNER WEAR PROTOCOL

MERLIYA JOHN1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月26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
40
试验地点
1
主要终点
To assess the change in expression of IL-6 in subjects with one-week aligner wear

研究概览

简要总结

According to orthodontic literature (IL-6) is a proinflammatory cytokine that is expressed in GCF, which controls the bone remodeling process through interactions with different types of bone cells. IL-6 is believed to play a positive regulatory role in osteoclast differentiation by inducing the expression of receptor activator of NF- kappa B ligand (RANKL) on the surface of osteoblasts . When orthodontic pressures are applied, IL-6 expression in the periodontal tissue increases . There are many research that has examined the expression of interleukin-6 in PDL and GCF, in patient following a fixed orthodontic treatment regimen.In CAT two week change protocol was widely used worldwide, until recent times when the one-week aligner protocol is been practiced. There have been many clinical studies comparing the accuracy of tooth movements in 7 days,10 days, and 14 days wear protocol which concluded that all three groups showed similar tooth movement and pain perception even though slight variation existed depending on the type of tooth movement.Studies have proven that up and down-regulation of cytokines depends on the amount of force given and it also diminishes differently in patients wearing clear aligners and fixed orthodontic treatment. Limited studies were conducted which evaluated the expression of different cytokines including IL-6 in the GCF of patients following a one-week aligner wear protocol. No comparative study between one-week and two-week aligner wear protocol has been done based on changes in the expression of cytokine brought about by clear aligners, making it difficult to evaluate the correct change in protocol and the effectiveness of these appliances.Therefore, it is crucial to reevaluate the molecular and biological basis for updating clear aligners wear protocol. The purpose of the study is to quantify the level of IL-6 in GCF in patients following two different aligner wear protocols and to correlate the results for redesigning the wear protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Patients who had no history of previous orthodontic treatment.
  • Good control of oral hygiene.
  • No anti-inflammatory or antibiotic therapy in the previous 6 months.
  • Adult patients who are compliant for CAT.
  • Patient with no periodontal disease 5)Permanent dentition excluding third molars 6) Patient with no systemic disease 7)Patient with good posterior occlusion.

排除标准

  • Smoking habit 2)Signs of gingivitis and periodontitis 3)Caries or restoration in anterior teeth 4) Autoimmune disease 5)Pregnant and lactating patients.

结局指标

主要结局

To assess the change in expression of IL-6 in subjects with one-week aligner wear

时间窗: To assess the change in expression of IL-6 in subjects with one-week aligner wear | protocol and two-week aligner wear protocols at different time intervals

protocol and two-week aligner wear protocols at different time intervals

时间窗: To assess the change in expression of IL-6 in subjects with one-week aligner wear | protocol and two-week aligner wear protocols at different time intervals

次要结局

  • To obtain the gingival status of patients at the beginning of treatment and after one(month of CAT.)

研究者

发起方
MERLIYA JOHN
申办方类型
Other [SELF SPONSOR]
责任方
Principal Investigator
主要研究者

Merliya John

SCB DENTAL COLLEGE AND HOSPITAL CUTTACK

研究点 (1)

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