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临床试验/NCT03700866
NCT03700866Unknown不适用

Evaluation of Functional Versus IADT Splinting Times on Tooth Mobility After Surgical Extrusion of Permanent Anterior Teeth: A Randomized Controlled Trial

Cairo University0 个研究点目标入组 22 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
22
主要终点
Tooth mobility

研究概览

简要总结

The objective of this study is to compare functional splinting time effect versus the suggested splinting time of (IADT) effect on tooth mobility and possible healing outcomes for surgically extruded permanent anterior teeth with crown root fracture.

详细描述

Trauma involving the tooth supporting tissue, especially luxation injuries, is considered the most severe with consequences such as neurovascular disruption, pulp necrosis, and root resorption. Healing depends on factors such as the level of root development, the extent of damage to periodontal tissues, and the effects of bacterial contamination from the oral cavity .

The course of healing of the severed periodontal ligament will determine the treatment outcome of these injured teeth .As a result, all treatment procedures are directed to minimize undesired consequences which might lead not only to loss of tooth, but also to loss of alveolar bone.

The common treatment of luxated teeth is repositioning and splinting to achieve stability and to prevent further damage to the pulp and periodontal structures during healing. Splints should ensure adequate fixation, prevent accidental ingestion or inhalation, and should protect teeth against traumatic forces during the vulnerable healing period .

The current guidelines for treatment of traumatic injuries by the International Association of Dental Traumatology (IADT) specify a short term functional splint for luxated teeth. However these protocols are based on clinical studies and animal experimentation employed rigid fixation techniques so the results of these investigations are not representative of the current protocols . Also splinting times in IADT guidelines are derived mainly from animal studies which considered of low quality evidence .

As a result of, surgical tooth extrusion as treatment modality in cases of crown root fracture was chosen as a controlled traumatic injury to examine the true cause-effect relationship between splinting time and healing outcomes of periodontal ligament aiming to decrease the effect of bias, con-founders and probability of chance associated with the other types of luxation injury.

研究设计

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

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Permanent anterior tooth/teeth with crown root fracture that needs surgical extrusion.
  • Complicated or uncomplicated crown root fracture.
  • Vital or necrotic tooth/ teeth.
  • Mature or immature tooth /teeth.

排除标准

  • Medically compromised patient
  • Tooth suffered any type of luxation injury to decrease the risk of root resorption
  • When root resorption is evident during the initial radiographic examination.
  • Teeth with dilacerated root to avoid pulp necrosis and periapical infection that occur without any evident decay in these teeth as the central lumen of the root constitutes a pathway for bacteria.
  • When root resorption is evident during the initial radiographic examination.
  • Teeth with dilacerated root to avoid pulp necrosis and periapical infection that occur without any evident decay in these teeth as the central lumen of the root constitutes a pathway for bacteria.

研究组 & 干预措施

(Functional splinting time)

Experimental

Teeth with crown root fracture will be surgically extruded and splinted then the Periotest values will determine when the splint should be removed which will indicate the functional periodontal healing and as well the functional splinting time.

The Periotest readings will be repeated with one week time interval between each series When the Periotest values of the traumatized tooth reach or even approximate the values of the corresponding normal tooth the splint will be removed.

干预措施: Functional splinting time (Procedure)

(IADT splinting time)

Active Comparator

Teeth with crown root fracture in this group will be surgically extruded and splinted for two weeks according to the international association of dental traumatology (IADT) splinting time two ,weeks splinting, regardless the Periotest score.

干预措施: Functional splinting time (Procedure)

结局指标

主要结局

Tooth mobility

时间窗: 9 months

Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)

次要结局

  • marginal bone resorption(9 months)
  • Root resorption(9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maii Mohamed Mohamed Mohamed Ali

Assistant Lecturer of Pediatric Dentistry and Community Dentistry, Faculty of Dentistry, Cairo University, Egypt

Cairo University

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