3D-Printed Custom Versus Conventional Band-and-Loop Versus Chairside Denovo Space Maintainers in the Primary Dentition: A Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Appliance Survival Rate
研究概览
简要总结
Purpose of the Study When a child loses a "baby" molar early due to a cavity or injury, the surrounding teeth can shift into the empty space. This often blocks the permanent adult tooth from growing in correctly. To prevent this, dentists use a small metal device called a space maintainer.
This study aims to find out which of three different types of space maintainers lasts the longest, is most comfortable for the child, and is most efficient for the dental office to provide.
The Three Study Groups
Children in this study are randomly assigned to one of three groups:
- 3D-Printed Custom Group: The dentist takes a digital picture (scan) of the child's mouth instead of a traditional mold. A custom-fit appliance is then 3D-printed using a specialized, medical-grade clear material.
- Conventional Band-and-Loop Group: This is the traditional method. The dentist takes a physical mold of the teeth, which is sent to a laboratory. The child usually has to return for a second appointment a week later to have the metal appliance glued into place.
- Denovo Chairside Group: This uses a kit of pre-made metal parts. The dentist selects the best fit and assembles the appliance right at the chairside, allowing it to be placed during a single visit.
What is Being Measured?
Researchers are following the children for 12 months to track:
Survival: Which appliance stays glued in and doesn't break most effectively?
Time: How much time does the dentist spend making and fitting the appliance?
Comfort: How much discomfort or pain did the child feel during the process?
Health: Does the appliance cause any irritation to the gums or surrounding teeth?
Who Can Participate? The study includes children between the ages of 5 and 10 who have lost at least one primary (baby) molar early and need a space maintainer to protect their future adult smile.
Importance of This Research By comparing these three methods, this study helps dentists understand if newer technologies, like 3D printing or pre-made kits, are better or more convenient than the traditional lab-made metal loops used for decades. This information will help families choose the best treatment for their children.
详细描述
Clinical Workflow and Device Fabrication
The trial compares three distinct manufacturing and clinical delivery pathways for pediatric space maintenance:
- 3D-Printed Custom Workflow (Experimental Arm)
Data Acquisition: Digital impressions are captured using a high-precision intraoral scanner (3Shape TRIOS).
Design Phase: The STL files are imported into CAD software (exocad), where a custom space maintainer is designed with a specific focus on anatomical adaptation to the abutment tooth and the edentulous ridge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 5 to 10 years
- •Premature unilateral loss of at least one primary first or second molar
- •Radiographically confirmed developing permanent successor at Nolla developmental stage 4 to 7
- •Parent or legal guardian able and willing to provide written informed consent, and child able to provide age-appropriate assent
排除标准
- •Systemic disease affecting bone metabolism or tooth development
- •Clinically significant mesiodistal space loss at screening, defined as greater than 3 mm
- •Poor oral hygiene precluding band placement, defined as a full-mouth plaque score greater than 50%
- •Known allergy or hypersensitivity to stainless steel or resin components
- •Current participation in another interventional clinical trial
研究组 & 干预措施
3D-Printed Custom Space Maintainer
Participants in this arm receive a custom-designed space maintainer fabricated through a fully digital workflow. This involves an intraoral scan (3Shape TRIOS) and CAD design (exocad). The appliance is 3D-printed using stereolithography (SLA) technology (Formlabs Form 3B+) with BioMed Clear Resin, a biocompatible photopolymer. The appliance is bonded to the abutment tooth using a light-cured orthodontic adhesive during a single or subsequent clinical visit.
干预措施: 3D-Printed Custom Space Maintainer (Device)
Conventional Band-and-Loop
This arm represents the current clinical reference standard. Fabrication follows a traditional analog workflow beginning with an alginate impression and stone model. A stainless steel band (3M Unitek) is fitted to the model, and a stainless steel wire (0.036-inch) is hand-contoured and silver-soldered to the band. The completed appliance is polished and cemented using glass ionomer cement in a second clinical appointment.
干预措施: Conventional Band-and-Loop Space Maintainer (Device)
Denovo Chairside Space Maintainer
This arm utilizes a prefabricated, chairside system (Denovo Dental) designed for single-visit delivery. A pre-sized stainless steel band is selected and fitted directly to the patient's tooth. A pre-formed wire loop is then adjusted for the appropriate span and mechanically secured to the band using a specialized crimping and locking tool, eliminating the need for laboratory soldering. The appliance is cemented during the same appointment as the initial fitting.
干预措施: Denovo Chairside Space Maintainer (Device)
结局指标
主要结局
Appliance Survival Rate
时间窗: At 12 months from baseline
This measures the clinical longevity and "success" of the appliance. A "failure" is recorded if the appliance becomes completely or partially dislodged (cement failure), suffers a structural fracture, or causes significant soft-tissue trauma requiring its removal.
Space Maintenance Effectiveness:
时间窗: At 12 month from baseline
Measured as the change in the mesiodistal dimension of the extraction space (in millimeters). Digital calipers or software will compare the initial space at baseline to the space remaining at the end of the study.
次要结局
- Clinical and Laboratory Time (Efficiency)(At baseline)
- Gingival Health (Löe and Silness Index):(Baseline, at 6 months, and at 12 months.)
研究者
Murad Alrashidi
Assistant Professor Orthodontics and Pediatric Dentistry
Qassim University