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临床试验/NCT06393699
NCT06393699招募中不适用

Restoration of Non-carious Cervical Lesions: The Effect of Different Resin Composites Bonded With A Universal Adhesive Utilizing Two Adhesion Approaches: A Randomized Clinical Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年5月14日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
Retention

研究概览

简要总结

patients with non carious cervical lesions suffer from dentin sensitivity and presence of cavitations and gingival recession. Restoring these lesions with different composites and evaluation of restorations every 6 months will be done to know the effect of different composite types and consistencies in retention of restorations of such lesions.

详细描述

A split-mouth randomized clinical trial (RCT), based on the adhesion strategy, will be held on 52 patients attending to the outpatient clinics of the department of operative dentistry, Faculty of Dentistry, Ain Shams University with 2 non-carious cervical lesions in each side. Patients included in this study are those who seek restorative treatment of non-carious cervical lesions (NCCLs) in premolars and canines, which are due to chemical and/or mechanical predisposing factors. An informed consent will be signed by all participants who will be allocated in this study before being involved in the study. Male and female patients will be selected according to the inclusion and exclusion criteria. The patients will be randomly assigned into 4 main groups (n=13 patients/group) according to the type of restorative material will be inserted. In each group, two adhesive approaches will be employed, either etch-and-rinse (E&R) or self-etching (SE)approach. For each patient's mouth, one side will receive restorations with the etch-and-rinse approach (n=26 restorations/E&R approach), while the other side will receive restorations using the self-etching approach (n=26 restorations/SE approach). This will result in a total of 208 restorations will be inserted in this study. A treatment follow-up will be performed every six months for two years to investigate the clinical performance of the different resin composite restorations/the two different adhesive approaches.

Restorations will be evaluated at baseline and every 6 months by two blinded examiners, who will not be involved in the study. During evaluation, the examiners will not be informed about the type of restoration used or the adhesive approach and will have a code for each patient and the restored tooth. Restorations will be evaluated according to the modified United State Public Health Service criteria (USPHS).(6,9,13,30) Primary outcome will be the retention of the restoration, but the following secondary outcomes as marginal discoloration and adaptation, anatomic form, secondary caries, texture, and postoperative sensitivity will be also evaluated.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients' age will range from 18 to 65 years.
  • Presence of at least 2 NCCLs in one side.
  • Patients with no medical condition could interfere with the routine dental care.
  • Patients who will be able to attend for each recall visit.
  • Patients with healthy periodontal tissues.
  • Cavities presenting no more than 50% of margins in enamel.

排除标准

  • Medically compromised patients.
  • Pregnant or breast-feeding patients.
  • Patients undergoing orthodontic treatment or bleaching treatment in the time of the study.
  • Patients with periodontal disease in the target area.
  • Patients presented with less than 20 teeth in the oral cavity.
  • Patients without antagonists.
  • Lesions superimposed with caries

结局指标

主要结局

Retention

时间窗: 18-24 months

ability of resin composite restorations to be retained in the non carious cervical lesions

次要结局

  • marginal staining(18-24 months)

研究者

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

Aisha Ahmed Elbaz

Principle investigator

Ain Shams University

研究点 (1)

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