Clinical Performance and Remineralization Potential of Self- Assembling Peptide P11-4 Containing Fluoride Versus Er, Cr: YSGG Laser Treatment and Micro Tensile Bond Strength of Giomer Restoration in Carious Lesions
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 21
- 主要终点
- Marginal integrity of restorations
研究概览
简要总结
This study will be performed in two parts, in vivo and in vitro to assess the effect of the remineralization potential of self-assembling peptide P11-4 containing Fluoride on caries-affected dentin compared to untreated caries-affected dentin and the influence of Er, Cr: YSGG Laser treatment.
详细描述
The present study will be performed to evaluate the remineralization potential of the self-assembling peptide P11-4 combined with fluoride treatment applied over demineralized dentin in occlusal carious molars.
- Research objectives: To assess the effect of the two treatment modalities to enhance remineralization of demineralized dentin and clinical performance of restorations.
- Research question: Will pretreatment of caries affected dentin using self-assembling peptide P11-4 containing fluoride compared to untreated caries-affected dentin will enhance the remineralization and clinical performance of composite restorations In Vitro Study
1- The present study will be performed to evaluate the remineralization potential of the self-assembling peptide P11-4 combined with fluoride and its effect on bond strength and analyze morphological changes over demineralized dentin in occlusal carious molars using Scanning Electron Microscopy (SEM).
- Research Objectives: To evaluate the effect of Curodont Repair Fluoride Plus and Er,Cr:YSGG laser pretreatment on the bond strength of composite resin to superficial and deep dentin.
- Research question: Will pretreatment of caries affected dentin using self-assembling peptide P11-4 containing fluoride compared to untreated caries-affected dentin will enhance bond strength?
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)
盲法说明
- Eligible patients will be randomly assigned to the intervention or control group using computer-generated random numbers.
- Allocation concealment will be ensured using sealed opaque envelopes.
- Clinical evaluators assessing outcomes will be blinded to the group allocation to reduce bias.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •o Patients aged (20 - 40) years.
- •Presence of at least one posterior permanent molar with an occlusal carious lesion classified as ICDAS code 3 or 4 requiring operative treatment.
- •Good general and oral health.
- •Willingness to participate and provide informed consent.
排除标准
- •o Patients with systemic conditions affecting oral health or healing.
- •Teeth with pulp involvement or periapical pathology.
- •Allergy to study materials.
- •Poor oral hygiene or periodontal disease in the target tooth region.
研究组 & 干预措施
Curodont Repair Fluoride Plus (P11-4 + fluoride)
• In the Intervention group the Curodont Repair (P11-4 + fluoride) will be applied according to the manufacturer's instructions: The paste is gently applied to the dentin surface and left undisturbed for 5 minutes to allow self-assembly and infiltration and excess material will be removed with a gentle air spray
干预措施: Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland (Drug)
Curodont Repair Fluoride Plus (P11-4 + fluoride)
• In the Intervention group the Curodont Repair (P11-4 + fluoride) will be applied according to the manufacturer's instructions: The paste is gently applied to the dentin surface and left undisturbed for 5 minutes to allow self-assembly and infiltration and excess material will be removed with a gentle air spray
干预措施: Beautifil II LS (Drug)
Beautifil II LS
No pretreatment; proceed directly to bonding. Then the surface will dry with absorbent paper. A layer of the adhesive system (BeautiBond extrem, Shofu Inc., Kyoto, Japan) will be actively applied for 20 seconds using a micro brush. Then, the adhesive will light-cure for 10 seconds with Radii-cal LED light curing device (1200 mW/cm2) (SDI, Bayswater, Australia) (2
干预措施: Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland (Drug)
Beautifil II LS
No pretreatment; proceed directly to bonding. Then the surface will dry with absorbent paper. A layer of the adhesive system (BeautiBond extrem, Shofu Inc., Kyoto, Japan) will be actively applied for 20 seconds using a micro brush. Then, the adhesive will light-cure for 10 seconds with Radii-cal LED light curing device (1200 mW/cm2) (SDI, Bayswater, Australia) (2
干预措施: Beautifil II LS (Drug)
结局指标
主要结局
Marginal integrity of restorations
时间窗: 6 months and 12 months
Assessed using mirror and probe according to Modified USPHS Criteria
Clinical longevity of restorations
时间窗: 6 and 12 months
Assessed by restoration retention using mirror and probe
Overall clinical performance of restorations
时间窗: 6 and 12 months
Evaluated using Modified USPHS Criteria
次要结局
- Postoperative hypersensitivity(6 and 12 months)
- Marginal discoloration(6 and 12 months)
- Recurrent caries(6 and 12 months)
- Surface roughness(6 and 12 months)
- Surface luster(6 and 12 months)
研究者
Fatheya Mansour Elshinawy
Assistant lecturer of Restorative Dentistry
Misr University for Science and Technology