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临床试验/NCT03644537
NCT03644537Unknown不适用

Correlation Between Root Resorption and Dentin Sialoprotein Upon Application of Different Orthodontic Forces, a Split-mouth Technique, a Randomized Clinical Trial

Aya Ahmed Moursi El Faham1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2017年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
27
试验地点
1
主要终点
DSP (DentinSialoProtein )

研究概览

简要总结

Since root resorption is a frequent consequence of orthodontic treatment, DSP are non-collagenous dentin-specific matrix proteins postulated to be involved in the mineralization of pre-dentin into dentin. Calculating the amount of DSP -Dentine Sialo Protein- produced upon root resorption might be an indicative biological marker for root resorption

详细描述

Histological and radiographic observations have shown that root resorption is a frequent consequence of orthodontic treatment (Reitan, 1974; Rygh, 1977; Harry and Sims, 1982). In most patients this resorption is minor and of no importance. A few teeth however exhibit severe resorption. In a study by Goldson and Henrikson (1975) it was found that 6 per cent of 924 teeth were resorped more than 2 mm after treatment with a Begg appliance and Malmgren et al. ( 1982) found a similar degree of root resorption in 10 percent of 264 incisors treated with an edgewise appliance and in 5 percent of 176 incisors treated with a Begg appliance(1).

Root resorption resulting from undesirable orthodontic force is an unwanted sequele , that fears all orthodontists including their experts as well(2).

DSP are non-collagenous dentin-specific matrix proteins postulated to be involved in the mineralization of pre-dentin into dentin (3,4) .Dentin undergoes continuous deposition throughout life as a secondary dentin only on the pulpal surface. Therefore, these proteins are not routinely released into the surrounding space as dentin does not undergo the process of remodeling as in bone. It is only in the presence of active external root resorption that these proteins could be freed into the periodontal ligament space(5).

Since periapical -intraoral- radiograph gives a two dimensional information, which detect root resorption after 60- 70% of the mineralized tissue is lost. (6) So, it's not sensitive in detecting early root resorption so in this study the investigators introduce the biological marker DSP to monitor root resorption from its onset by collecting samples from the GCF -gingival crevicular fluid- for its detection.

Calculating the amount of DSP -Dentine Sialo Protein- produced upon root resorption might be an indicative biological marker for root resorption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Adolescent female patients age ranging from 15- 18 yrs, with the full set of the permanent dentition.
  • No previous orthodontic treatment.
  • Class I crowding or Class II malocclusion whose treatment requires extraction of first maxillary premolars.
  • Adequate oral hygiene.

排除标准

  • Systematic diseases.
  • Bad Oral hygiene.
  • Missing permanent teeth (except for third molars).
  • Uncontrolled Pathological Conditions that may contra-indicate immediate orthodontic treatment (caries, gingivitis, periodontitis).

研究组 & 干预措施

heavy force 100gm

Other

heavy intrusive force is to be applied on a first premolar on one side

干预措施: Orthodontic intrusion (Procedure)

medium force 25 gm

Other

medium intrusive force is to be applied on a first premolar on one side

干预措施: Orthodontic intrusion (Procedure)

light force 10 gm

Other

light intrusive force is to be applied on a first premolar on one side

干预措施: Orthodontic intrusion (Procedure)

结局指标

主要结局

DSP (DentinSialoProtein )

时间窗: with in 3 monthes from applied intrusion

concentration of DSP is expected to be secreted into the gingival crevicular fluid upon root resorption

次要结局

未报告次要终点

研究者

发起方
Aya Ahmed Moursi El Faham
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aya Ahmed Moursi El Faham

Principal investigator

Cairo University

研究点 (1)

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