Comparative Evaluation of the Conventional and Three-Dimensional Printed Lower Lingual Arch Space Maintainers A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Patient satisfaction and pain experienced using the Wong-Baker Faces Test
研究概览
简要总结
the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.
详细描述
Introduction and Review of literature Primary teeth serve to preserve inborn space until permanent teeth erupt, in addition they help with speech and mastication. It is appropriate to highlight the primary dentition's function as the best space maintainer for permanent teeth. It is possible that premature primary tooth loss will cause undesirable primary and permanent tooth movements, including a loss in arch length. If there is not enough arch length, it is more likely to predict malocclusions such as crowding and ectopic eruption as well as tooth impaction.
Since the largest space loss occurs within a month of losing the deciduous teeth, it is best to use a space maintainer as soon as possible after early tooth loss. Space maintainers are the orthodontic appliance of choice for preventing space loss because they preserve space within the oral cavity.
Conventional space maintainers have significant drawbacks despite their clinical effectiveness. These include the need for patient compliance, extended chairside times, multiple steps in the fabrication process, technique-sensitive impressions and lab procedures, solder failure, and caries formation at band margins.
These disadvantages in the conventional space maintainer recommend the need for more advanced appliance designs and materials, one of which is three-dimensional (3D) printing, The process involves creating 3D objects using a digitally scanned and layered design of the entire object. The design is preserved using a "Standard Tessellation Language" (STL) file.
So, the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apparently, healthy cooperative children have recently prematurely loss of more than one mandibular primary molar in any of the quadrants, full erupted mandibular first permanent molars in both sides, and whose lower permanent incisors have erupted
- •The permanent successors of the lost primary molars were not expected to erupt within 6 months
- •Angle's class 1 occlusion with normal primary molar relation
- •Caries-free and periodontally healthy abutment teeth
- •Absence of parafunctional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite.
- •Children's age ranges from 7 to 9 years-old
- •Radiographically, presence of permanent successors, more than one millimeter of bone covering the successor tooth germ, and/or only about one-third of the root of the permanent tooth has been formed.
- •Parents and children were accepting the new treatment modality.
排除标准
- •children exhibited poor oral hygiene, para-functional oral habits, severe crowding, space loss, and abnormal occlusion
- •Extraction of primary molars exceeding three months.
- •Radiographically, absence of permanent successor.
- •uncooperative children
研究组 & 干预措施
Group I
Conventional spacemaintainer
干预措施: Conventional spacemaintainer (Device)
Group II
3D printed spacemaintainer
干预措施: 3D printed spacemaintainer (Device)
结局指标
主要结局
Patient satisfaction and pain experienced using the Wong-Baker Faces Test
时间窗: 9 months
Patient satisfaction and pain experienced during conventional and digital impression and cementation will be evaluated using the Wong-Baker Faces test and subsequently recorded for clinical satisfaction at 3 months, 6 months and 9 months for both patient groups to evaluate appliance acceptance and convenience for the patients.
Gingival health will be evaluated using Sillness and Loe Gingival Index
时间窗: 9 months
gingival health will be evaluated by Sillness and Loe Gingival Index Evaluation of the gingival health according to the (GI) described by (Loe and Silness, 1963): Score Criteria for the Gingival Index 0 No inflammation. 1. Mild inflammation: slight redness, slight edema, no bleeding on probing. 2. Moderate inflammation: redness, edema, glazing, bleeding on probing. 3. Severe inflammation: marked redness and edema, ulceration, and a tendency of spontaneous bleeding.
次要结局
- Impression taking experience for the patient assessed by 6-questions survey(Day 1)
研究者
Reham Mohamed
Assistant Professor
Suez Canal University