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临床试验/NCT05606874
NCT05606874已完成不适用

Retention Rate and Caries Preventive Effect of Preheated Flowable Resin Composite Used as a Pit and Fissure Sealant Versus Conventional Resin-based Fissure Sealant in Patients With Permanent Molars With Deep Pit and Fissure Over One Year Follow up. A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年11月20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
入组人数
28
试验地点
1
主要终点
Retention rate

研究概览

简要总结

Retention rate and caries preventive effect of preheated flowable resin composite used as a pit and fissure sealant versus conventional resin-based fissure sealant in patients with permanent molars with deep pit and fissure over one year follow up. A randomized clinical trial

详细描述

Statement of the problem:

Pit and fissure sealant placement is considered as an effective modality for prevention of caries on occlusal surfaces. Penetration, retention and lateral wall adaptation are the key factors in success of pit and fissure sealant restorations .

The retention is very critical for the sealing material and the successful penetration of the material into the pits and fissures However, the morphology of the fissures significantly influences the penetration of the sealing material occlusal fissure pattern like in deep and narrow fissures like I-type and IK- type where lesser penetration may be encountered fillers are added to the pit and fissure sealants in order to increase their wear and abrasion resistance. However, these fillers could lead to increase in the viscosity with subsequent decrease in the penetration.

Rationale:

According to a systematic review, they found that preheating of resin composite apparently increases the flowability of regular consistency composites, which improves the adaptation of the material into the cavity walls. Also studied the effect of heat and sonic vibration on penetration of flowable resin composite, they found that higher penetration was associated with heat compared with the conventional application method. So, this proposal is introduced with the hypothesis that preheating of filled fissure sealants may enhance their flowability and penetration especially into those fissures with complex structure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •participant:
  • •Young adults (16_22y)
  • •Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
  • •Permanent molars teeth without any caries and cavitation. (Azarpazhooh & Main 2008)
  • •Permanent molar teeth that have deep pit and fissure morphology, with "sticky" fissures.
  • •Permanent molar teeth with stained grooves.
  • •Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).

排除标准

  • •participant:
  • •Uncooperative behavior, limits the use of sealants due to hampering of adequate field or isolation techniques throughout the procedure.
  • •Patients allergic to sealant material.
  • •Patient with history of medical disease, drug therapies or any other serious relevant problem.
  • •An individual with no previous caries experience and well coalesced pits and fissures
  • •Partially erupted teeth.
  • •Teeth with cavitation or caries of the dentin.
  • •A large restoration is present on occlusal surface.
  • •If pits and fissures are self-cleansable.
  • •Teeth with dental fluorosis, hypocalcification or hypercalcification

研究组 & 干预措施

Pre-heating of flowable resin composite .

Experimental

(Filtek™ Z350Xt Flowable Restorative, 3M ESPSE, USA)

干预措施: Pre-heating of flowable resin composite used as a pit and fissure sealant. (Other)

Conventional resin fissure sealant

Active Comparator

(total etch), (UltraSeal XT®, Ultradent, USA)

干预措施: Conventional resin fissure sealant (Other)

结局指标

主要结局

Retention rate

时间窗: T3: 12 months

Retention criteria

Retention rate

时间窗: T1: 3 months

Retention criteria

Retention rate

时间窗: T2: 6 months

Retention criteria

次要结局

  • Caries incidence(T3: 12 months)
  • Caries incidence(T1: 3 months)
  • Caries incidence(T2: 6 months)

研究者

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

safa abd alwahab natiq

operator, data entry and corresponding author; B.D.S. Cairo University (2016), Conservative Dentistry Department, Faculty of Dentistry, Cairo University. Egypt

Cairo University

研究点 (1)

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