Evaluation of Clinical Performance for Recently Introduced Non Coated Glass Ionomer in Occlusal Caries in Posterior Teeth Compared to Conventional Glass Ionomer With Coating: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Distance penetrated by the Explorer at the tooth restoration interface
研究概览
简要总结
In patients with occlusal caries in posterior teeth, does the use of recently introduced non coated glass ionomer provide better clinical performance compared to conventional glass ionomer with surface coating?
-Primary objective: To evaluate clinical performance of different types of restorations (Ketac molar with coating and Ketac Universal Aplicap 3M without coating) in occlusal caries in posterior teeth.
详细描述
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Mahmoud Magdy Eldamanhory
Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University
- Local anesthesia will be applied to patients complaining about pain or sensitivity to prevent discomfort during restorative procedures.
- Conservative cavity design will be used according to the principals of minimal invasive dentistry.
- All the cavities will be performed by the main author using #57 straight plain carbide fissure bur held in high speed contra-angled hand piece with water cooling system.
- All internal line angles will be slightly rounded.
- Each bur will be discarded after 5 preparations
- If deep caries will be found, it will be removed with large round bur at low speed and a thin layer of calcium hydroxide will be placed on the deep portion of the cavity.
- Isolation will be maintained by using Rubber Dam.
- The dentin and enamel of cavities will be conditioned with 20% polyacrylic acid for 20 seconds (Cavity Conditioner, GC), washed, and briefly dried.
- The restorations will inject into the cavity.
- After the passage of the manufacturer's recommended setting time of 2.5 minutes, the restoration will be trimmed and polished wet using high-speed fine diamonds.
In control group ketac molar with coating:
-After the restoration will briefly dry, Ketac Coat will be applied and photocured for 20 seconds using a photo-curing light.
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
Double Blinded (Participant and Outcome assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least 2 carious class I in same patient.
- •The absence of tooth mobility.
- •Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth.
- •Accessible isolation and observable and easily accessible.
排除标准
- •Patients with poor oral hygiene. According to DMF or ADA criteria.
- •The presence of any para functional habit.
- •Abnormal occlusion.
- •Any regurgitation problem.
- •Subjects with compromised medical history.
- •Pulpitis, non-vital or endodontically treated teeth.
结局指标
主要结局
Distance penetrated by the Explorer at the tooth restoration interface
时间窗: 12 months
The explorer will be drawn across the surface of the restoration toward the tooth
Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
时间窗: 12 months
Visual inspection and explorer to check the shape and structure of the restoration
The degree of mismatch from the normal range of tooth shades and translucency
时间窗: 12 months
Visual inspection to check the proximity of the shade from the natural tooth
Distance penetrated along the restoration in a pulpal direction
时间窗: 12 months
Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
时间窗: 12 months
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Area of continuous movement of an explorer across the surface of the restoration
时间窗: 12 months
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Pain due to dentin hypersensitivity (evaporative stimulus)
时间窗: 12 months
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
次要结局
未报告次要终点
研究者
Mahmoud Magdy Eldamanhoury
Principal investigator
Cairo University