Clinical Evaluation of the Proximal Contact Tightness and Location in Class II Composite Restoration Using Different Contact Forming Instruments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in proximal contact tightness
研究概览
简要总结
This study aims to investigate consecutive biological changes in proximal contact tightness using digital force gauge and evaluate proximal contact location using cone beam computed tomography between class II direct composite restorations and adjacent teeth after using sectional matrix system and with different contact forming instruments.
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)
盲法说明
Each case will be represented by a code and the group name. These will be sealed in a sequentially numbered opaque envelope and the set of envelopes will be given to the senior supervisor. When the investigator wants to enroll a new case, he will notify the supervisor who will take the next inline envelope and will write the name of the participant on it. At the time of intervention implementation, the investigator will open the sealed envelope and retrieve the allocation and apply.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of proximal caries in CBCT x-ray with score 3 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS).
- •Presence of the antagonist and the adjacent tooth making contact.
- •The teeth to be restored had to show no signs of pulpitis but positive sensitivity using endo ice testing.
- •Size of the isthmus with no more than 2/3 of the intercuspal distance
- •Good oral health and absence of periodontal disease
- •Patients who are not suffering from severe systemic diseases or allergies
排除标准
- •Medically compromised patients
- •Clinical signs of bruxism, traumatic malocclusion
- •Pregnant or breast feeding at the time of restoration placement
- •Intolerance or allergy toward the applied restorative materials
结局指标
主要结局
Change in proximal contact tightness
时间窗: baseline, immediately postoperative, 1 month, 3 month, 9 month, and 12 month
Proximal contact tightness (PCT) will be measured using the custom-made contact pressure system that was based on the tooth pressure meter, a device fabricated at the University of Technology, Delft, the Netherlands. (20) The system will use a 0.05-mm-thick metal strip inserted interdentally from An occlusal direction . The metal strip will be connected to the digital force gauge (Mark-10 series 2 digital force gauge). The tightness of the proximal contact will be quantified as the maximum frictional force when the strip will slowly removed in a buccal-lingual direction. The maximum force will be recorded on the screen of the gauge for each measurement when the gauge will be switched to peak-mode
次要结局
- Change in proximal contact location(baseline and immediately postoperative)
研究者
karim mohamed
Clinical instructor at faculty of dentistry Alexandria university
Alexandria University