Retention Rate of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 19
- 主要终点
- retention rate evaluation of both restoration
研究概览
简要总结
Pits and fissures have been considered as the single most important feature leading to the development of occlusal caries; About 90 % of carious lesions are found in the pits and fissures of permanent posterior teeth .Several materials and techniques have been developed to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure sealants
详细描述
Pits and fissures have been considered as the single most important feature leading to the development of occlusal caries; About 90 % of carious lesions are found in the pits and fissures of permanent posterior teeth . The complex morphology of occlusal pits and fissures makes them an ideal site for retention of bacteria and food remnants, rendering the performance of proper hygiene difficult or even impossible .
Several materials and techniques have been developed to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure sealants . However, the clinical longevity of flowable composite as fissure sealants is directly related to their retention, where the percentage of rate of retention differ on a 12-month follow-up examination were the partial loss rate of flowable composite material ranges from 15.5% to 16.5% and total loss were ranged from 12.7% to 13%, while on a 24-month follow-up examination the partial loss rate ranged from 18.1% to 20% and total loss rate ranged from 15.6% to 17%, and that depends on morphology of pits and fissures, adequate isolation, conditioning of enamel, application techniques, particular material characteristics like viscosity, surface tension, adequate adhesion and penetration of the material into the previously etched system of fissures.
In order to overcome the shortcomings of traditional dental composites, nanofibers or nanotubes fillers are broadly used in the academia and industry. The type of Nanofibers and Nanotubes used to reinforce dental resin composites include polymeric nanofibers, metallic nanofibers, and inorganic hydroxyapatide (HAP) nanofibers. The Hydroxyapatite Nanofibers are calcium phosphates fillers that allow the release of mineral from dental resin composite. Also HAP nanofibers possessing sufficiently high slenderness ratios and relatively long and thin structure, and create a lot of bonding points in the interface with polymeric matrix. When the composites suffer from huge pressure this allow tremendous stress transfer from weak polymeric matrix to tough HAP nanofibers; and consequently increase the mechanical properties of resin composite. So this study will examine the effect of adding HAP nanofibers on the clinical performances and retention rate of flowable resin composite.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The primary assessors will not be blind to intervention/control material due to different in material shade. However, the other assessors will be blind from the type of material they will evaluate the retention rate of the restoration; it will not be allowed amongst the assessor to exchange any information throughout the entire study period.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients should be over 18 Years old. Patient should have good oral hygiene and general health. Patient with at least 2 non-cavitated initial occlusal carious lesion in first and/or second molar teeth in each quadrant of maxilla or mandible.
排除标准
- •Known allergy to any of the resins used. Clinically detectable cavitated carious lesion. Previously placed sealants or restorations. Bruxism or malocclusion.
研究组 & 干预措施
NovaPro™ Flow
NovaPro™ Flow Flowable Composite, Nanova Biomaterials company, USA
干预措施: Hydroxyapatite Nanofiber reinforced flowable composite (Other)
NovaPro™ Flow
NovaPro™ Flow Flowable Composite, Nanova Biomaterials company, USA
干预措施: conventional resin-based flowable composite (Other)
Conventional resin-based flowable composite
Filtek™Supreme Ultra Flowable Restorative, 3M ESPE company, USA
干预措施: Hydroxyapatite Nanofiber reinforced flowable composite (Other)
Conventional resin-based flowable composite
Filtek™Supreme Ultra Flowable Restorative, 3M ESPE company, USA
干预措施: conventional resin-based flowable composite (Other)
结局指标
主要结局
retention rate evaluation of both restoration
时间窗: 12 months
restoration will be evaluated after 12 months by two investegators who ar blinded for the material used for the restoration.Each restoration will be independently evaluated using a mirror, blunt explorer, and air stream as the follows: Full retention (FR): the materials were fully present on the occlusal surfaces. Partially lost (PL): the materials were present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed. Totally lost (TL): no trace of materials was detected on the surface.
次要结局
未报告次要终点
研究者
safinaz hussien fahmy hassan
dental resident
Cairo University
