Evaluation of Resin Infiltrate As Pit and Fissure Sealant in Permanent Molars (In Vivo& in Vitro)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria.
研究概览
简要总结
The aim of this study is to evaluate and compare the clinical effectiveness of ICON resin Infiltration versus conventional sealant and the microleakage and penetration depth of the two sealant materials.
详细描述
Using the resin infiltration technique as a different approach for sealing pits and fissures creates a diffusion barrier as resin infiltrate tends to inhibit enamel pores that serve as diffusion channels for acids and dissolved minerals within the lesion body. A low-viscosity resin that can penetrate into caries lesions, which is referred to as resin infiltration technique. The mechanisms associated with this method depend on the infiltration of subsurface lesions with low-viscosity light-curing resins after eroding the highly mineralized surface layer and increasing penetration depth. This method is believed to overcome the limitations of sealant applications and is considered to be a better alternative for the treatment of initial caries lesions.
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, Investigator, Outcomes Assessor)
盲法说明
For the application of ICON, The cleaned fissure was etched using an Icon-Etch in its special syringe for 2 minutes. Then the tooth was rinsed off using water for at least 30 seconds and dried with oil-free and water-free air. Followed by application of the Icon-Dry applied into the fissure and let sit for 30 seconds. The excess of the Icon-Dry was removed and dried with oil-free and water-free air.an ample amount of Icon-Infiltrate is applied into the fissure away from the direct light of the dental unit and let sit for 3 minutes. After excess removal, it will be cured with a light source* according to the manufacturer's instructions. A second layer of the Icon Infiltrate was applied and cured in the same way.
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of the children from 6 to 8 years.
- •Healthy children free from any systemic disease.
- •Show bilaterally sound fully erupted lower first permanent molars with deep narrow central fissures and supplemental grooves.
- •The eruption time of these molars should not exceed 3 years.
- •No sign of pain or active periodontal disease in the selected teeth.
排除标准
- •Children with fillings or sealants in the selected teeth.
- •Children with clinical evidence of caries in the selected teeth either white spot lesions or cavities.
- •Children with an allergy to any drug, such as resin restorative material.
- •Children with Extremely poor oral hygiene.
- •Hypoplastic teeth.
- •Children with bruxism.
研究组 & 干预措施
ICON resin infiltration group (in vivo)
The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK)
干预措施: ICON resin infiltration Material group in vivo (Drug)
Resin-based fissure sealant group (in vivo)
The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)
干预措施: Resin-based fissure sealant group in vivo (Drug)
ICON resin infiltration Material (in vitro)
The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK)
干预措施: ICON resin infiltration in vitro (Drug)
Resin-based fissure sealant (in vitro)
The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)**
干预措施: Resin-based fissure sealant in vitro (Drug)
结局指标
主要结局
Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria.
时间窗: 3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 months
172 permanent mandibular molars out of 86 children will be randomly allocated into two equal groups. Group 1: The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK). Group 2: The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael).For application of ICON, an ample amount of Icon-Infiltrate is applied into the fissure away from the direct light of the dental unit and let sit for 3 minutes. After excess removal, it will be cured with a light source. A second layer of the Icon Infiltrate was applied and cured in the same way. For Heliosael application, The sealant will be carefully applied starting from the maximum depth of the central fissure up towards two. Sealant retention will be evaluated using Simonsen's criteria. (Completely present: no sealant ledge is present, Partially present: part of the sealed pit or fissure, Complete missing: no sealant ledge is present.
次要结局
- Evaluate and compare the microleakage and penetration depth of the two sealant materials(thirty seconds for application of Heliosael.The children will be recalled at 3, 6, and 9 months)
研究者
Salsabeel Mahmoud Abdelgaffar Shalaby
Dentist, Pediatric dentistry, Oral Health and Preventive Dentistry Department
Tanta University