跳至主要内容
临床试验/NCT06119126
NCT06119126已完成2 期

Clinical Efficacy of SDF and Laser in Preventing Initial Caries Progression With and Without Fissure Sealants in Primary and Permanent Molars

British University In Egypt1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
23
试验地点
1
主要终点
Number of molars with arrested initial decay

研究概览

简要总结

Primary Objective:

Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars.

Secondary Objective:

Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.

详细描述

Primary Objective:

Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars.

Scoring caried out by ICDAS Scoring criteria over a 1 year follow up period

Secondary Objective:

Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • .Uncooperative or mentally challenged patients, with bad oral hygiene or rampant caries.
  • .Patients providing history of bruxism or clenching affecting the posterior occlusion were excluded.
  • .Children with known allergies or sensitivities to resins or silver products. .Molars that showed well-coalesced, self-cleansing pits & fissures or shallow grooves and severe forms of hypoplasia / fluorosis were excluded.
  • .Patients & parents with high esthetic demands and concerns. .Unmotivated patients, or parents who refused to sign the consent form.

研究组 & 干预措施

Group A

Experimental

Diode laser application only

干预措施: Diode Laser (Device)

Group B

Experimental

SDF application only

干预措施: SDF1 (Drug)

Group C

Experimental

Diode laser application followed by pits and fissure sealant.

干预措施: Diode Laser (Device)

Group C

Experimental

Diode laser application followed by pits and fissure sealant.

干预措施: Pit Fissure Sealant (Drug)

Group D

Experimental

SDF application followed by pits and fissure sealant.

干预措施: SDF1 (Drug)

Group D

Experimental

SDF application followed by pits and fissure sealant.

干预措施: Pit Fissure Sealant (Drug)

结局指标

主要结局

Number of molars with arrested initial decay

时间窗: 1 year follow up

ICDAS II Score system

次要结局

  • Number of molars with completely retained f pits and fissure sealants(1 year follow up)

研究者

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

Islam el guindy

Assistant Lecturer in Pediatric Dentistry

British University In Egypt

研究点 (1)

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