Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Diagnodent scoring
研究概览
简要总结
Background: Subjecting human dental enamel to sub-ablative laser has been suggested as a novel way of caries prevention. However, further studies are needed to establish its use as a routine clinical procedure for caries prevention.
The aim of this study: This study aims to evaluate the effect of Er,Cr:YSGG subablative laser irradiation on caries resistance of occlusal fissures of permanent molars.
Materials and methods: In-vivo study, a split mouth randomized controlled trial with sixty patients having two fully erupted bilateral first permanent molars (ICDAS-II score 0,1 or 2). The pits and fissures will be subjected to sub-ablative power of Er,Cr:YSGG Laser (Group 1, n=90) and will be compared with fluoride varnish application on the first permanent molars in the same arch(Group 2,n=90). DIAGNOdentTM readings and changes in ICDAS-II score will be assessed at base line and at 3,6,9 and 12 months follow-up.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants of age 6-12 years old
- •Patients ranking definitely positive or positive on Frankl behavior rating scale
- •Having at least two bilateral fully erupted first permanent molars with untreated non-cavitated occlusal surfaces with deep grooves, the included teeth will have International Detection and Assessment System (ICDAS-II)/ severity scores 0, 1 or 2
- •Initial DIAGNOdent Score not exceeding value of 25 indicating only enamel involvement
- •Patients whom their parents are willing to comply with all study procedures and protocols and will be given an informed consent to participate
排除标准
- •Patients with any known medical history of systemic diseases
- •Patients having first permanent molar with hypoplastic or hypocalcified enamel
- •Patients using medications that may affect the oral flora or salivary flow
- •Patients treated with in-office fluoride treatment within the last 3 months prior to being enrolled in the study.
- •Patients showing evidence of poor oral hygiene according to Silness and Löe plaque index
研究组 & 干预措施
Laser irradiation
First permanent molars subjected to sub-ablative Er,Cr:YSGG laser
干预措施: sub-ablative Er,Cr:YSGG laser (Procedure)
Fluoride Varnish
First permanent molars subjected to fluoride varnish application
干预措施: Fluoride varnish application (Procedure)
结局指标
主要结局
Diagnodent scoring
时间窗: day 0, 3 months, 6 months, 12 months
evaluate the dental caries activity of fissures by comparing changes in DIAGNOdent readings. Laser induced fluorescence (DIAGNOdentTM) will be used to quantitatively determine lesion demineralization which is displayed as numerical values ranging from 0 to 99. A decrease in the signal indicates regression of the carious lesion, whereas an increase indicates progression. The DIAGNOdent tip will be then placed on the measurement site, and slightly tilted circular movements will be performed along the entire fissure pattern. The patient will be included in the study if the DIAGNOdent readings of both bilateral first permanent molar do not exceed 25.
次要结局
未报告次要终点
研究者
Hussein Ezz
Assistant Lecturer, Pediatric dentistry department, Faculty of dentistry
Alexandria University