A Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Retention Versus Conventional Pits and Fissure Sealant With and Without Fissurotomy in Permanent Molars: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Sealant retention
研究概览
简要总结
This RCT study aims to establish evidence-based decision comparing between self-adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) and conventional resin-based pits & fissure sealant Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) with and without fissurotomy in sealant retention and prevention of occlusal pits and fissures caries in first permanent molars over a 12-month follow-up.
详细描述
This randomized controlled clinical trial aims to compare the retention and clinical performance of a self-adhering flowable composite and a conventional resin-based pit and fissure sealant, applied with and without fissurotomy, in newly erupted permanent first molars of children aged 6-8 years.
Occlusal pits and fissures are highly susceptible to dental caries in children, and long-term sealant effectiveness is strongly dependent on material retention and technique sensitivity. Self-adhering flowable composites offer simplified application with fewer clinical steps and may improve retention, especially in pediatric patients.
Eighty-eight children will be randomly allocated into four parallel groups (1:1:1:1): self-adhering flowable composite with fissurotomy, self-adhering flowable composite without fissurotomy, conventional resin-based sealant with fissurotomy, and conventional resin-based sealant without fissurotomy.
Sealant retention will be assessed as the primary outcome using Simonsen's criteria, while secondary outcomes include caries development, marginal discoloration, and marginal integrity evaluated using Ryge criteria.
Clinical evaluations will be performed at baseline, 3, 6, and 12 months.
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)
盲法说明
The blinding of the operator is not possible due to the nature of the materials used and fissurotomy preparation
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
- •Normal healthy children aged 6 to 8 years.
- •Children with high caries risk
- •Completely erupted lower first permanent molars with deep pits and fissures.
- •Fissures either intact, sound or retentive which are stained, caries free or ICDAS 0-
- •Availability for the duration of the study.
- •Satisfactory dental care performed at home.
排除标准
- •Children whose parents refuse to sign informed consent.
- •Long-term medication affecting the salivary flow.
- •Children enrolled for other studies or fluoridation program.
- •Adverse reaction reported to any dental material.
- •Uncooperative child.
- •Bruxism or malocclusion.
- •Children with developmental defects/ hypoplastic molars or caries affected teeth (ICDAS>2).
- •Teeth with restoration and partially retained sealants.
- •Children who cannot come for the follow-up.
研究组 & 干预措施
Self adhering flowable composite Vertise™ Flow with fissurotomy
Vertise™ Flow (Kerr, Orange, CA, USA)
Chemical composition:
- Resin: GPDMA, HEMA, BisGMA, catalysts.
- Fillers: Prepolymers, silanated Ba-glass, SiO2,YF3 (70 wt%). This SAFC uses the adhesive monomer glycerophosphate dimethacrylate GPDM, a phosphate functional group that creates a chemical bond with the calcium ions of the tooth. GPDM monomers ensure a tenacious bond to enamel, evidenced by the strength known to all generations of the OptiBond adhesive family.
干预措施: Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy. (Other)
Self adhering flowable composite Vertise™ Flow without fissurotomy
Vertise™ Flow (Kerr, Orange, CA, USA)
Chemical composition:
- Resin: GPDMA, HEMA, BisGMA, catalysts.
- Fillers: Prepolymers, silanated Ba-glass, SiO2,YF3 (70 wt%). This SAFC uses the adhesive monomer glycerophosphate dimethacrylate GPDM, a phosphate functional group that creates a chemical bond with the calcium ions of the tooth. GPDM monomers ensure a tenacious bond to enamel, evidenced by the strength known to all generations of the OptiBond adhesive family.
干预措施: Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy. (Other)
Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.
Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity
Sealant Matrix Composition:
- Bis-GMA
- UDMA
- TEGDMA Fillers: Fluorosilicate glass , highly dispersed silicon dioxide, pigments, initiators.
干预措施: Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy. (Other)
Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.
Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity
Sealant Composition:
- Bis-GMA
- UDMA
- TEGDMA Fillers: Fluorosilicate glass , highly dispersed silicon dioxide, pigments, initiators.
干预措施: Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy. (Other)
结局指标
主要结局
Sealant retention
时间窗: 3,6,12 months
Simonsen's criteria Score 1: Complete retention Score 2: Partial loss Score 3: Complete loss
次要结局
- Presence of Caries(3,6,12 months)
- Marginal discoloration(3,6,12 months)
- Marginal Integrity(3,6,12 months)
研究者
Eman Mohamed Mostafa Ramadan
Principle investigator
Cairo University