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临床试验/NCT02939417
NCT02939417Unknown不适用

One Year Clinical Evaluation of E.Max Laminate Veneers With and Without Using Grape Seed Extract as a Natural Collagen Cross-linking Agent Before Bonding

Marwa Salem0 个研究点目标入组 16 人开始时间: 2016年11月1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
16
主要终点
Retention of laminate veneers

研究概览

简要总结

The aim of this study is to evaluate the clinical performance of E-max veneers cemented with and without using grape seed extract before bonding.

详细描述

Justification for undertaking the trial:

Ceramic veneers have become a popular dental procedure since its introduction because they provide excellent esthetics.1 Achieving the good esthetic results especially with ceramic veneers is probably the most challenging task encountered by dental practitioners and ceramist today. Ceramic veneers are indicated for teeth with moderate discoloration, restoration of traumatized, fractured, worn dentition and abnormal tooth anatomy.2 Many factors affect the long term success of ceramic laminate veneers. The most repeated failure patterns associated with ceramic laminate veneer were fractures, microleakage, colour change and detachment of restoration.3 The main reasons for failure were large marginal defect and fractures.4 The clinical performance of ceramic veneer has shown that the estimated survival rate for the teeth prepared with butt joint design are higher than for the teeth prepared with palatal chamfer design.5 The bonding technique, which is a time-consuming and technique sensitive procedure, is a key to the long-term success of these types of restorations. The strength and the durability of the bond between the porcelain, the luting cement and the enamel/dentin interface play an important role in the outcome of ceramic veneers, particularly when dentin is involved. 6

Expected benefits for the patient

  1. Achieving a more predictable esthetic restoration while being conservative. 2. Increasing the long term prognosis of the restoration. Expected benefits for the clinician

  2. Enriching the professional skills of the dentist with a new material to improve the clinical performance of the restoration.

  3. Improving the confidence in the patient-dentist relationship.

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
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients between 20-40 years old, able to read and sign the informed consent document.
  • •Patients having teeth with exposed dentin surface limited to cervical third.
  • •Patients, healthy physically and psychologically, able to tolerate conventional restorative procedures.
  • •Patients don't have active periodontal or pulpal diseases and have teeth with good restorations.
  • •Patients with normal occlusion.
  • •Patients with teeth problems indicated for laminate veneer (e.g. discoloration, mild malposition, fracture not involving more than 50% enamel loss, ....)
  • •Patients willing to return for follow-up examination and evaluation.

排除标准

  • •Patients in the growth stage with partially erupted teeth.
  • •Patients with fractured teeth with more than 50% enamel loss.
  • •Patients with poor oral hygiene and lack of motivation.
  • •Pregnant women.
  • •Patients with abnormal occlusion (eg. edge to edge, deep bite, ...)
  • •Patients with parafunctional habits (eg. Bruxism, biting on hard objects, ...)
  • •Patients with endodontically treated teeth.
  • •Lack of opposite occluding dentition in the area intended for restoration.
  • •Psychiatric problems or unrealistic expectations.

研究组 & 干预措施

without uing grape seed extract

Active Comparator

干预措施: Grape seed extract (Other)

using grape seed extract

Experimental

Grape seed extract as collagen cross-linking agent

干预措施: Grape seed extract (Other)

结局指标

主要结局

Retention of laminate veneers

时间窗: 1 year

using USPHS criteria for clinical evaluation

Fracture of laminate veneers

时间窗: 1 year

using USPHS criteria for clinical evaluation

Marginal adaptation of laminate veneers

时间窗: 1 year

using USPHS criteria for clinical evaluation

次要结局

未报告次要终点

研究者

发起方
Marwa Salem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marwa Salem

Marwa Salem

Cairo University

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