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临床试验/NCT06273410
NCT06273410已完成不适用

Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive (A Randomized Controlled Clinical Trial)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年10月13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
36
试验地点
1
主要终点
Change in pain sensitivity

研究概览

简要总结

Despite significant advances in composite materials, they are still perceived as technique-sensitive and exhibit failure related to excessive wear and polymerization shrinkage. Cention N is a recently introduced alkasite restorative that contains special reactive fillers. Its application in restorative dentistry may be significant, promoting remineralization of carious lesions & reduction of polymerization shrinkage. The study will aim to compare the clinical performance of Cention N (with and without adhesive) and composite resin (Filtek Bulk Fill) in class I restorations using FDI criteria. Thirty-six class I cavities will be selected and equally allocated into 3 groups: Group I (n=12): (Cention N with adhesive), Group II (n=12): (Cention N without adhesive) & Group III (n=12): composite resin (Filtek Bulk Fill) in class I cavities. Patients will be followed up at 1 week 3, 6, and 12 months and evaluated using the FDI criteria. Postoperative sensitivity, staining, and recurrent caries will be evaluated in this clinical trial.

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 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Permanent molars with occlusal pit and fissure caries.
  • •Good oral hygiene.
  • •Occlusal contact with antagonist teeth.

排除标准

  • •Permanent molars with occlusal pit and fissure caries.
  • •Good oral hygiene.
  • •Age between 18- 45 years.
  • •Occlusal contact with antagonist teeth.

研究组 & 干预措施

Filtek Bulk Fill posterior composite

Active Comparator

干预措施: Bulk Fill Composite (Other)

Cention N without adhesive.

Experimental

干预措施: Cention N (Other)

Cention N with adhesive

Experimental

干预措施: Cention N + Adhesive (Other)

结局指标

主要结局

Change in pain sensitivity

时间窗: 1 week, after 3, 6 and 12 months

Air spray will be applied from a 2-mm distance on to the occlusal surface for 35seconds and should always be compared with the reaction of adjacent vital teeth. The severity of patients' pain/sensitivity will be recorded and given a score from 1 to 5

Change in occurrence of marginal stains

时间窗: 1 week, after 3, 6 and 12 months

It is recommended to ask the patient about dietary habits. The restoration surface will be evaluated with regard to staining by comparison with the surrounding hard tissues and will be performed by the means of visual inspection aided with intraoral photography

Change in occurrence of recurrent caries

时间窗: 1 week, after 3, 6 and 12 months

All surfaces were dried prior to evaluation. The restorations' assessment will be performed using a dental mirror and a ball-point probe aided by periapical radiographs.

次要结局

未报告次要终点

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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