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临床试验/NCT04351048
NCT04351048Unknown不适用

The Evaluation of Stepwise and One Step Excavation Techniques In The Management of Deep Dentin Lesions

TIJEN PAMIR0 个研究点目标入组 40 人开始时间: 2016年12月12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
40
主要终点
Pulpal Success Assessment

研究概览

简要总结

This double blind, randomized, controlled clinical trial aimed to observe the success of stepwise (SW) and one step (OneS) excavation techniques in the management of deep dentin caries. Additionally, evaluation of glass ionomer cement (GIC) as temporary restorative was also performed. For this purpose, forty participants were selected among the routine patients coming to university clinic. A permanent tooth having caries lesions penetrating to 75 percentage or more of dentin of patient were included. Randomization to SW and OneS groups were organized by coin method. The periphery of the cavities including enamel-dentin junction was cleaned until reach to hard dentin. Afterwards, selective removal to soft dentin on the pulpal side of the cavities was applied manually excavation and covered with pure calcium hydroxide and zinc oxide eugenol cement. GIC was used for temporary filling. This process was implemented both the first stage excavation of SW and OneS groups. Clinical and radiographic evaluations were performed at 6 months according to clinical signs and symptoms and radiographic sings using Periapical Index (PAI). Besides, temporary restorations were evaluated according to the of Ryge/Modified USPHS criteria. Following this evaluation, on the SW group, the cavities was re-entered and selective removal was applied up to firm dentin and pulp-capping were applied as mentioned above. In OneS group, temporary restoration was reduced as a base. All of the cavities were permanently restored with resin composite. Whole procedure was completed at one centre by a specialist, and control sessions was performed two experienced experts. Participants and experts were blinded in this study.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Molar teeth with primary caries lesion prolonged of 75 percentage or more of dentin radiographically1 Existence of vitality with positive response to
  • •electrical pulp test and
  • •cold test
  • •No history of spontaneous pain on the teeth
  • •No sign of pain on percussion and palpation (sensitivity)

排除标准

  • •Individuals with the systemic disease who require hospitalization (oncological treatment, transplantation patients)
  • •Patients with uncontrolled hyperglycaemia or using insulin
  • •Patients with pregnancy/suspected
  • •Observation of radiolucency in the apex of the relevant tooth (PAI> 2)
  • •Secondary decayed teeth

研究组 & 干预措施

SW

Experimental

stepwise excavation

干预措施: Stepwise Excavation (Procedure)

OneS

Experimental

one step excavation

干预措施: One Step Excavation (Procedure)

结局指标

主要结局

Pulpal Success Assessment

时间窗: a 6-month periods

Presence of vitality in treated tooth with positive response to electrical and thermal stimuli, no history of spontaneous pain and no response to percussion and pain (sensitivity) sign in palpation

Health Status of Periapical Tissue

时间窗: a 6-month periods

According to Orstavik' Periapical Index (PAI), Periapical Index score scale are 1to 5 : scoring with PAI 1 or PAI 2 refer to healthy tooth but PAI 3, PAI 4 and PAI 5 as worse outcome for periapical tissue that sing of periapical tissue damage

次要结局

未报告次要终点

研究者

发起方
TIJEN PAMIR
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

TIJEN PAMIR

Prof Dr

Ege University

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