Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer and Its Impact on Children's Oral Health Status: A Randomized Controlled Clinical Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- clinical evaluation
研究概览
简要总结
Primary dentition is the most suitable space maintainer for permanent teeth. However, as infants often lose their primary teeth too soon, using a space maintainer is the most efficient, long-lasting, and economical way to prevent malocclusions and function impairment in the future. Regarding personalized appliances, space maintainers in digital pediatric dentistry have made significant progress. Digital technology decreases the manual manufacturing stages that take a long time and increases the reliability and durability of digital fabrication procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 having recent premature loss of lower primary molars
- •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
- •Presence of teeth on the mesial and distal side of the edentulous area
- •Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite.
- •Radiographically, presence of permanent successors.
- •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
conventional acrylic partial denture space maintainer
an elastomeric impression will be done to produce a plaster cast then a conventional acrylic partial space maintainer will be fabricated and delivered for the child patient.
3-D printed partial denture space maintainer
A 3-D intraoral scanner will be used to produce digital models. STL file will be used to design a 3-D printed partial denture space maintainer which will be delivered to the child patient.
结局指标
主要结局
clinical evaluation
时间窗: three months
the clinical performance of the partial denture space maintainers in the recall visits will be to assess: the Fracture of the space maintainer, and Lost or missing
gingival health
时间窗: three months
using a Williams periodontal probe, gingival index will be evaluated according to the following criteria: * 0: Healthy gingiva. * 1: There is mild inflammation, discoloration and edema, no bleeding on probing. * 2: Moderate inflammation, marked redness, edema, and bleeding on probing. * 3: Severe inflammation, prominent redness and edema, ulceration, spontaneous bleeding tendency.
plaque index
时间窗: three months
using a Williams periodontal probe, the plaque index will be assessed using the Silness-Loe plaque index: 0: Absence of microbial plaque, 1: Thin film of microbial plaque along the free gingival margin, 2: Moderate accumulation with plaque in the sulcus, 3: Large amount of plaque in the sulcus or pocket along the free gingiva margin.
次要结局
未报告次要终点
研究者
Shaimaa Shaban Mohamed El-desouky
assistant professor of pediatric dentistry
Tanta University