Assessment of Clinical, Radiographical Efficacy, Operator Ease and Satisfaction and Patient Comfort in Restoring Class II Cavities in Primary Molars With Fender Mate System Versus T-Band System: An in Vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Clinical assessment of Proximal Contact Points
研究概览
简要总结
this study aims to evaluate and compare the clinical and radiographical efficacy, operator ease, satisfaction and patient comfort in restoring class II cavities in primary molars using Fender Mate system with T-band system.
详细描述
Restorations of posterior primary teeth can have a number of issues, including incorrect contact points and proximal overhangs. With the recognition of significance of restoring tooth's right contour and contact, and repair of all tooth surfaces, including proximal walls, different matrix systems were introduced,so this study aims to evaluate and compare the clinical and radiographical efficacy, operator ease, satisfaction and patient comfort in restoring class II cavities in primary molars using Fender Mate system with T-band system.
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)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy children free from any systemic diseases.
- •Patients showing Frankel's positive and definitely positive behavior.
- •Parent willing to participate in the study and signed on informed consent.
- •Each child has at least two carious primary molars (class II) bilaterally, indicated for composite restoration with criteria as follow: -
- •No history of spontaneous pain or provoked pain.
- •Fully erupted teeth.
- •Fully erupted adjacent tooth.
- •Caries involving two surfaces - proximal and occlusal
- •Absence of clinical signs or symptoms suggesting a non-vital tooth such as sinus tract, soft tissue swelling, mobility or tenderness to percussion.
- •No pathological external or internal root resorption.
排除标准
- •Patients showing Frankel's negative and definitely negative behavior.
- •Children having primary molars with:
- •Caries involving less than or more than two surfaces
- •Extensively damaged teeth
- •Missing adjacent tooth.
- •Mobility.
- •Spaced dentition.
结局指标
主要结局
Clinical assessment of Proximal Contact Points
时间窗: Baseline
clinically assessment of the Proximal Contact Points using waxed dental floss in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix.
Radiographically Assessment of proximal overhangs
时间窗: Baseline
Radiographically Assessment of the proximal overhangs using bite wing radiograph in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix.
Assessment of operator ease and satisfaction
时间窗: Baseline
-Assessment of operator ease and satisfaction using questionnaire in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix, which includes: 1. time needed to install the matrix system (more time means worse outcome) 2. Ease of application and removal of matrix system which may be Easy, Manageable or Difficult (Difficult means worse outcome) 3. Trauma to gingival tissue while applying and removing matrix system which may be Present or Absent (Present means worse outcome) 4. Dislodgment/displacement of restoration while removing matrix system which may be Yes or NO (Yes means worse outcome)
Assessment of patient comfort
时间窗: Baseline
* Assessment of patient comfort using Wong Baker pain rating scale in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix. * Wong Baker pain rating scale with scores from 0-10 (higher scores mean a worse outcome).
次要结局
未报告次要终点
研究者
Noha Elsayed Fathi Abdou
Lecturer at Pediatric Dentistry Department, Preventive Dentistry and Dental Public Health
Aswan University