Evaluation of a New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions
One-Year Clinical Evaluation of a Fluoride, Calcium and Phosphate-Releasing New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions: A Randomized Clinical Trial.
- This study will be conducted to evaluate and compare the clinical performance of fluoride, calcium, and phosphate-releasing new bioactive material versus a fluoride-releasing hybrid restorative material in cervical lesions for one-year follow-up.
- The clinical evaluation will be done using modified USPHS criteria at baseline,3,6,9 and 12 months.
研究概览
详细说明
two groups of 30 patients will receive cervical restorations by using calcium and phosphate releasing hybrid restorative material (Activa™ Presto, Pulpdent®, USA), or a fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). Then these restorations will be evaluated at baseline, 3 months, 6 months, 9 months, and 12 months according to modified USPHS criteria in terms of marginal adaptation, Marginal discoloration, recurrent caries, retention, surface texture, and Post-operative sensitivity.
- Examination and selection of all patients will be done according to inclusion and exclusion criteria.
- A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation followed by the placement of restorative material according to the randomization sequence.
- For the intervention: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride, calcium, and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA) using a 19-gauge applicator tip on the syringe and light-curing for 20 seconds between each 2mm layer.
- For the control group: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan) and will be light polymerized using a light-emitting diode (LED) light-curing unit for 10 seconds between each 2mm layer.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Nourhan K Mohamed, B.D.S
- 电话号码：01003787886
- 邮箱：nourhankhaled@dentistry.cu.edu.eg
学习地点
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Maadi
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Cairo、Maadi、埃及、11728
- Nourhan Khaled Mohamed Samir
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接触：
- Nourhan K Mohamed, B.D.S.
- 电话号码：002 01003787886
- 邮箱：Nourhankhaled@dentistry.cu.edu.eg
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首席研究员：
- Nourhan K Mohamed, B.D.S
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
a)Inclusion Criteria of participants:
- Male or female gender.
- Only co-operative patients will be approved to participate in the trial.
- Medically free adult patients.
- The age range of the patients is 18-40 years. b)Inclusion Criteria of teeth:
- Small to moderate cervical lesion.
- Vital upper or lower teeth with no signs of irreversible pulpitis.
- Caries extension shouldn't exceed mesiodistal width and inciso(occluso)-gingival length not exceed incisal (occlusal) one third.
Exclusion Criteria:
a)Exclusion criteria of participants:
- Allergic history concerning methacrylates
- Pregnancy
- Heavy smoking; xerostomia
- Lack of compliance
- Patients with disabilities.
- Patients having systemic diseases or severe medically compromised.
Patients with severe bruxism, clenching, or temporomandibular joint disorders.
b)Exclusion criteria of the teeth:
- Deep defects (close to the pulp, less than 1 mm distance).
- Periapical pathology or signs of pulpal pathology.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism.
- Pulpitis, non-vital or endodontically treated teeth.
- Sever periodontal affection.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Fluoride, calcium and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA).
ACTIVA Presto is a novel bioactive material with a mineral-enriched hydrophilic resin base and a patented rubberized component that resists abrasion and wear with high release and recharge of not only fluoride but also calcium and phosphate ions.
It doesn't contain BIS-GMA, Bisphenol A, or BPA derivatives.
|
A class v cavity will be prepared after local anesthesia has been given as required.
Rubber dam isolation will be done.
Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces.
Followed by, placement of restorative material according to the randomization sequence.
Finally, restoration finishing and polishing will be done.
|
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有源比较器：Fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan).
Giomer is a hybrid restorative material that contains a resin base and pre-reacted glass ionomer.
S-PRG (surface reaction type) technology provides some properties of GI such as fluoride release and recharge which helps prevent recurrent caries.
|
A class v cavity will be prepared after local anesthesia has been given as required.
Rubber dam isolation will be done.
Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces.
Followed by, placement of restorative material according to the randomization sequence.
Finally, restoration finishing and polishing will be done.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Marginal adaptation
大体时间：one year
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The restoration will be clinically assessed by visual inspection and explorer. Restorations will be given a score using modified USPHS criteria: Alfa: Closely adapted, no visible crevice Bravo: Visible crevice, the explorer will penetrate Charlie: Crevice in which dentin is exposed |
one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Marginal Discoloration
大体时间：one year
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Clinical evaluation by visual inspection and mirror if needed using modified USPHS criteria. Restorations will be given the score: Alfa if No discoloration Bravo if Non penetrating marginal discoloration which can be polished away Charlie if Discoloration with penetration in pulpal direction. |
one year
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Retention
大体时间：one year
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Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria : Alfa if restoration is retained and there is no loss of restoration. Charlie if loss of restoration. |
one year
|
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Secondary caries
大体时间：one year
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Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria: Alfa if no recurrent caries is detected, charlie if recurrent caries is detected. . |
one year
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surface texture
大体时间：one year
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Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria: Alfa if restoration is enamel-like surface Bravo if Surface rougher than enamel, clinically acceptable Charlie if Surface is unacceptably rough. |
one year
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postoperative sensitivity
大体时间：one year
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Verbal evaluation by asking the patient. Restorations will be given a score according to modified USPHS criteria: Alfa if not present Bravo if sensitive but diminishing in intensity Charlie if constant sensitivity not diminishing. |
one year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
- Full protocol will be published online in Clinicaltrials.gov to avoid repetition, and keep the integrity of the research work.
- Thesis will be discussed and defended in front of a judging committee.
- The study will be published to report the results of this clinical trial.
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
- 知情同意书 (ICF)
- 临床研究报告（CSR）
- 解析代码
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