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临床试验/NCT07752147
NCT07752147进行中(未招募)不适用

Clinical Evaluation of 3D Printed vs CAD/CAM Rehabilitation of Primary Anterior Teeth Loss

Tanta University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Clinical survival rate

研究概览

简要总结

compare 3D Printed versus CAD/CAM fabricated modified fixed appliance for rehabilitation of premature loss of anterior teeth in preschool children

详细描述

The study will be conducted as a clinical trial and it will be carried out at Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. Forty preschool children from both genders aged from 3-5 years will be included in the study. The selected children will be divided into two groups.

Group I: Twenty children will receive 3D Printed modified fixed bridge. Group II: Twenty will receive CAD/CAM fabricated modified fixed bridge. Evaluation of both appliances will be carried out at baseline, 6 and 12 months

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
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children (ASA I or II)
  • Premature loss of one to four maxillary primary incisors
  • At least 6 months remaining before the expected eruption of the permanent successor
  • Presence of sufficient healthy abutment teeth (primary canines)
  • Adequate oral hygiene (Plaque Index ≤1).
  • Cooperative child (Frankl Behavior Rating 3, 4).

排除标准

  • Children with craniofacial anomalies or syndromes (e.g., cleft lip and palate).
  • Children with developmental dental anomalies affecting the anterior region (e.g., hypodontia, severe enamel defects).
  • Severe gingivitis or periodontal disease around the abutment teeth.
  • Deep bite, severe malocclusion, or traumatic occlusion that could interfere with appliance function.
  • Parafunctional habits that could increase appliance failure( Bruxism, Nail biting, Biting hard objects).
  • Persistent oral habits that may affect appliance stability

研究组 & 干预措施

3D Printed modified fixed bridge

Experimental

the modified fixed bridges were fabricated using 3D Printing technology

干预措施: 3D Printed modified fixed bridge (Device)

CAD/CAM fabricated modified fixed bridge

Active Comparator

the modified fixed bridges were fabricated using CAD/CAM technology

干预措施: CAD/CAM fabricated modified fixed bridge (Device)

结局指标

主要结局

Clinical survival rate

时间窗: 12 months

Debonding, breakage of appliance ( failure causes)

Gingival health

时间窗: 12 months

Gingival index will be assessed by clinician

Esthetic evaluation

时间窗: 12 months

child and parent evaluation of restoring child esthetics using visual analog scale

次要结局

  • Questionnaire(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

nora mostafa mohammed abo shanady

Lecturer of Pediatric Dentistry, Faculty of Dentistry, Tanta university

Tanta University

研究点 (1)

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