跳至主要内容
临床试验/NCT06375837
NCT06375837进行中(未招募)不适用

Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites in Non-carious Cervical Lesions

Hacettepe University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
33
试验地点
1
主要终点
Clinical performances of different restorative systems according to FDI criteria (Esthetic properties)

研究概览

简要总结

The clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. After recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. Lesions will be divided in three groups: an alkasite-based restorative material (Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)), hybrid resin composite (Gradia Direct Anterior, GC, Tokyo, Japan (GD)) and a highly filled flowable resin composite ((G-aenial Universal Flo, GC, Tokyo, Japan (GF)). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria. Descriptive statistics will be performed using chi-square tests.

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

入选标准

  • •Age range will be 18 to
  • •They will be required to have at least three NCCLs needed restoration in different teeth.
  • •All the NCCLs selected will be in similar sizes.

排除标准

  • •Patients with severe periodontal disease
  • •Patients with rampant, uncontrolled caries
  • •Patients with xerostomia
  • •Patients with serious medical problems preventing them from attending review visits
  • •Patients with poor gingival health
  • •Patients with heavy bruxism
  • •Patients with removable partial dentures
  • •Patients undergoing bleaching treatment or orthodontic treatment

研究组 & 干预措施

an alkasite-based restorative material

Experimental

Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN) The liquid and powder will be mixed and then applied according to manufacturer's instructions.

干预措施: an alkasite-based restorative material (Device)

hybrid resin composite

Experimental

Gradia Direct Anterior, GC, Tokyo, Japan (GR) After applying 37% orthophosphoric acid to the enamel of the lesions for 30 seconds and to the dentin for 15 seconds, the acid will be washed with water and then dried with light air. A universal adhesive (G-Premio Bond, GC, Tokyo, Japan) and then the composite will be applied according to the manufacturer's instructions.

干预措施: hybrid resin composite (Device)

a highly filled flowable resin composite

Experimental

G-aenial Universal Flo, GC, Tokyo, Japan (GF) After applying 37% orthophosphoric acid to the enamel of the lesions for 30 seconds and to the dentin for 15 seconds, the acid will be washed with water and then dried with light air. A universal adhesive (G-Premio Bond, GC, Tokyo, Japan) and then the composite will be applied according to the manufacturer's instructions.

干预措施: a highly filled flowable resin composite (Device)

结局指标

主要结局

Clinical performances of different restorative systems according to FDI criteria (Esthetic properties)

时间窗: two years

Two year results according to FDI criteria. (Esthetic properties) The evaluations will be carried out using FDI criteria. Esthetic properties will be examined. Five scores will be given for each restoration: (1) Clinically excellent / very good, (2) Clinically good, (3) Clinically sufficient/satisfactory, (4) Clinically unsatisfactory, (5) Clinically poor.The data obtained for groups will be compared at each visit.

次要结局

  • Clinical performances of different restorative systems according to FDI criteria (Functional properties)(two years)

研究者

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

Dr. Fatma Dilşad Öz

Assoc. Prof. Dr.

Hacettepe University

研究点 (1)

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