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临床试验/NCT06299150
NCT06299150已完成不适用

Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children: Randomized Clinical Trial

October University for Modern Sciences and Arts2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Clinical success/ survival

研究概览

简要总结

Dental trauma (DT) of the incisors and their supporting tissues, one of the most challenging dental emergencies, requires immediate assessment and management due to psychological and physical reasons. This is especially important for young permanent teeth to minimize undesired complications. The treatment of dental trauma is sometimes neglected, although it might lead to pain, difficulty in articulation and mastication, and considerable negative effects on a patient's self-esteem. However, the aesthetics of the anterior teeth are very important aspects of human appearance and can be affected by many factors, including the presence of fillings, tooth color, position, alignment, shape, and number.

Rasmussen ST et al. discovered in 1981 that most children suffer from tooth trauma. According to their research, 25% of all schoolchildren and 33% of adults have undergone trauma, with the majority of cases occurring before the age of 19.

As the maxillary incisors are the most commonly injured teeth due to their exposed position, a functional, aesthetic, and time-efficient restoration is frequently demanded. According to the current International Association of Dental Traumatology guidelines, crown fractures confined to enamel and dentine may be treated either with a direct composite restoration or with an adhesive reattachment of the fractured fragment. As long as the fragment is intact, reattachment is often preferred in dental practice. This technique facilitates the restoration of the tooth with its original anatomy, color, and function in a minimum amount of time. Unfortunately, clinical studies regarding the survival of reattached fragments are scarce, and results from laboratory investigations cannot be transferred to clinical settings without limitations. Furthermore, longevity data of direct composite restorations in fractured anterior teeth are restricted to a few clinical studies.

In addition to the aforementioned restorative alternatives, the use of small partial glassy restorations-partial laminate veneers (PLVs), sectional veneers, or ceramic fragments has become increasingly popular over the last few years. PLVs are thin pieces of glass matrix ceramic fragments without a defined shape that are used to restore small defects in the anterior teeth. As tooth preparation is not required for this type of restoration, and minimal to no prep is accepted, the maximum amount of enamel surface structure is conserved. Thus, retention relies completely on adhesion, which is primarily achieved by bonding to the conditioned glassy surface. Despite their growing popularity, available data in the literature on PLVs are limited to a few in vitro studies and case reports, without any clinical information available at present.

Patients in all groups will receive a minimally invasive restoration with high esthetic advantages and long-term success of their fractured incisors (either conventional composite restoration, fragment reattachment, or partial laminate veneers) that require minimal to no preparation and do not require local anesthesia.

详细描述

Aim of the study:

This randomized clinical trial study will assess the survival and success rates of three different types of conservative restorations restored the Ellis Class II traumatized central incisors by clinical evaluation of the patients.

Research question:

Are the direct resin composite mini-veneer, reattachment of broken segments and IPS e.max CAD clinically successful techniques in restoring Ellis Class II traumatized central incisors in children?

PICOS:

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
Single (Participant)

入排标准

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

入选标准

  • 8-18 years old
  • Ellis Class II traumatized central incisors
  • Controlled dental disease - no active caries or periodontal diseases
  • Patients will be available to be clinically reviewed up to 1 year

排除标准

  • All Ellis Classification traumatized central incisors except Ellis Class II
  • Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
  • Poor oral hygiene and motivation.
  • Patients with parafunctional habits (e.g., bruxism, biting on hard objects).
  • Patients with debilitating illnesses or complicating medical conditions

研究组 & 干预措施

direct resin composite mini-veneer

Active Comparator

Composites resins have become the first choice for direct anterior and posterior restorations. The great popularity is related to their esthetic appearance and reduced need of sound tissue removal as compared with former treatments. Several studies have demonstrated that composite restorations may last long in clinical service. Composite restorations have demonstrated a good clinical performance with annual failure rates varying from 1% to 3% in posterior teeth and 1% to 5% in anterior teeth.

干预措施: IPS e.max CAD (Other)

IPS e.max CAD

Experimental

"IPS e max" likely refers to a type of dental material or technology. IPS e.max is a popular brand of lithium disilicate glass-ceramic used in dentistry for the fabrication of dental restorations such as crowns, veneers, inlays, onlays, and bridges.

IPS e.max restorations are known for their excellent esthetics, strength, and durability. They are designed to closely mimic the natural appearance of teeth while providing reliable performance and longevity. Dentists often choose IPS e.max restorations for their patients due to their versatility and ability to meet both esthetic and functional requirements.

干预措施: IPS e.max CAD (Other)

结局指标

主要结局

Clinical success/ survival

时间窗: 12 months

* Clinical success will evaluate using (a modified version of the United States Public Health Service (USPHS) criteria). \[Appendix A\] * Each parameter will assess using visual and tactile observations (probe and mirror). * At the checkup visits (3, 6, 9, 12 months), will take standardized photographs and the restorations will clinically evaluate by an independent and calibrated clinician. * The need for replacement and partial fractures (chippings) will define as failures

次要结局

未报告次要终点

研究者

发起方
October University for Modern Sciences and Arts
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Ahmed Salmoon

Principal Investigator

October University for Modern Sciences and Arts

研究点 (2)

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