Evaluation of Bio Compatibility of Bio-HPP Crown Veneered With Visio.Lign Compared to Lithium Disilicate (E-max) Crown Veneered With E-max Veneering System in Anterior Esthetic Zone (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- change in patient satisfaction(bleeding)
研究概览
简要总结
The aim of this study compare soft tissue reaction (bleeding, gingival color and texture), bacteria type and count in the gingival sulcus around the restoration margin and sulcus depth of Bio-compatible High performance polymer( Bio-Hpp) restorations to E-max regardless its popularity in the dental field.
详细描述
Roles and responsibilities:
- Esra'a Mohamed Ali Mraweh (E.M):Operator, data enterer and corresponding author;Assistant lecturer, Fixed Prosthodontics Department, Modern Technology and Information University (MTI University), Egypt.
- Dr. Hesham Alansary ( H.A):Main supervisor, data monitoring, auditing Professor, Fixed prosthodontics department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Nora Helmy (N.H):Outcome assessors and data collection;Assistant Lecturers, Fixed Prosthodontics department, Faculty of Oral and Dental Medicine, Modern Technology and Information University (MTI university), Egypt.
- Noha Moustafa (N.M):Base line data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants' consents;Resident, Fixed Prosthodontics Department, Faculty of Oral and Dental Medicine, Modern Technology and Information University (MTI University), Egypt.
- Eman Desouky (E.D.):Sample size calculation; Statistician,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Evidence Based Dentistry Committee (CEBD): Help in reporting study protocol following SPIRIT guidelines;Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Research Ethics Committee (CREC): Protocol reviewer of the clinical trial in order to protect the right, safety, dignity and well-being of the participants.
Faculty of Oral and Dental Medicine, Cairo University, Egypt.
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Research Plan Committee (CRPC): For ensuring that this clinical trial following the department research plan; Fixed Prosthodontic Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
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Intervention:E.M. will record the crevice depth and bacterial count prior to preparation. E.M. will perform full coverage conservative tooth preparation following principles of all ceramic crown preparation with shoulder sub-gingival finish line of thickness 1mm using tapered stone with flat end attached to high speed headpiece with air and water coolant after local anesthesia has been given as required.After tooth preparation, E.M will take an adequate 2ry Impression using non aqueous Elastomeric impression materials Impregum™F( medium consistency,3M ESPE) and bite registration, Pink Soft wax(Star dental supply)will be taken. E.M will fabricate the temporary restoration using composite resin temporary material Protemp™4 Temporisation Material (3M ESPE) and cemented using non Eugenol Zinc Oxide temporary cement TempBond™ Temporization( Kerr Dental).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age range of patients will be 20-40 years old, able to read and sign the informed consent document.
- •Patient will be able to physically and psychologically to tolerate conventional restorative procedures.
- •Patients have no active periodontal or pulpal diseases, no pockets, bone defects or resorption, have teeth with good restorations.
- •Patients with good Occlusion no para-functional habits
- •Patient with teeth with problems indicated for full coverage restoration (e.g. mild to moderate dislocation, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
- •Patients are willing to return for follow-up examination and evaluation.
- •Patient with sound contralateral tooth to the selected tooth required for full coverage.
- •Patient with root canal treated tooth requiring full coverage restoration
排除标准
- •Patient in the growth stage with partially erupted teeth.
- •Patient with poor oral hygiene and motivation.
- •Patients with periodontal disease, bony defects.
- •Pregnant women's.
- •Patient with psychiatric problems or unrealistic expectations.
- •Patients have no opposing occluding dentition in the area intended for restoration.
- •Patients with MalOcclusion and Parafunctional habits.
结局指标
主要结局
change in patient satisfaction(bleeding)
时间窗: 3,6,9 and 12 months
presence or absence of bleeding is noted in questionnaire.
次要结局
- Clinical biological outcome(crevice depth)(before preparation, immediately after crown delivery, 3, 6, 9 and 12 months)
- Clinical biological outcome(Bacteria count)(before preparation, immediately after crown delivery, 3, 6, 9 and 12 months)
研究者
Esraa Mohamed Ali Mraweh
assistant lecturer,Fixed Prosthodontic department,MTI University
Cairo University