Comparison of Bulk-fill Flowable and Packable Composite in Splinting of Luxation Injuries: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Time consumed to apply and remove the splint
研究概览
简要总结
The objectives of this randomized clinical trial (RCT) were:
- To compare the efficiency of splinting by two composite materials in terms of retention of material
- To compare adhesive point dimension between the two groups
- To compare time taken to place and remove the splint
- To assess the efficacy of bulkfill flowable in reducing mobility of luxated teeth.
详细描述
A Randomized control trial of 6 month period was done. Patients with luxation injuries aged between 16- 50 years were asked to participate in the study after taking informed consent. They were then assigned to either group (Group 1: Packable Composite (PC), Group 2: Bulkfill Flowable) by lottery method. Periotest was used to check the mobility of teeth before the placement of splint. Splinting was performed with composite material according to group allocation. Time taken to place the splint was recorded. Frontal view images of splinted teeth were taken with DSLR and transferred to Adobe Photoshop Version 22.4.1 for windows to measure surface area of the restorative material in percentage to total tooth surface area. Post-operative instructions were given. After 2 weeks, Periotest readings were recorded, immediately after removal of splint. On both visits 3 readings per tooth were recorded. Time taken to remove the splint was also recorded. Additionally, the retention of splint was also observed.
STATISTICAL ANALYSIS
SPSS version 26 for windows was used, the mean time taken to apply and remove the material and mobility before and after removal of splint was compared using the independent samples T test. Mann-Whitney test compared the percentage area of the material occupied. Fisher's Eaxct test evaluated the retention of splint material. Level of significance was kept at p ≤0.05.
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
The participants were unaware of the group allocation. In addition, the outcome assessments were performed by a blinded investigator
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Permanent dentition patients aged between 16-50 years
- •Either gender
- •Lateral and extrusive luxation injuries
排除标准
- •Patients with following conditions were excluded
- •Intrusion injuries
- •Root fracture
- •Dentoalveolar fracture.
- •Patients with systemic diseases.
- •Patients with periodontitis
- •Para-Functional habits
- •Non-consenting patients
结局指标
主要结局
Time consumed to apply and remove the splint
时间窗: 2 weeks
Application time: Amount of time taken in minutes from the beginning of splinting that is starting from applying the etchant till the last block of composite is cured. Removal time: The amount of time taken in minutes to remove the splinting material The outcome will be measured as amount time taken in mm:ss i.e. minute:second to apply and remove the splint in either group.
Tooth mobility
时间窗: 2 weeks
'Movement of tooth in its socket resulting from an applied force, usually measured on an increasing scale of 1-3, or measured by the amount of horizontal and/or vertical mobility in millimeters' The values of Periotest in assessment of tooth mobility is based on the scale given as: Grade 0: -0.8- +09 Grade I: +10- +19 Grade II: +20- +29 Grade III: +30- +50 The outcome will be measured as percentage of patients presenting with grade of tooth mobility before applying the splint and after removal of splint
Retention of splint
时间窗: 2 weeks
Retention will be measured as follows: Fully bonded: No exposure of wire on composite material and wire remained bonded to tooth. Partially debonded: Specs of composite remained on wire and wire remained bonded to tooth. Unbonded: wire is exposed to oral cavity with no composite on it and wire is detatched from tooth and freely movable. The outcome will be measured as percentage of cases reporting with condition of interest in each group.
Adhesive point dimension
时间窗: 2 weeks
Percentage of area occupied by the material in comparison to the tooth will be noted as adhesive point dimension. The outcome will be measured as percentage occupied by the splinting material of total tooth area as it is visible from the front. In our case the wire splint is retained by either Bulkfill composite or Packable composite. Therefore, the percentage of area occupied by the splinting material is the outcome of interest.
次要结局
未报告次要终点
研究者
Arshad Hasan
Head of Department, Operative Dentistry, Dow Dental College
Dow University of Health Sciences