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临床试验/NCT06583759
NCT06583759已完成不适用

Evaluation of Prefabricated CAD/CAM PEEK Crowns Used in Primary Molars: A Randomised Controlled Clinical Trial

Alexandria University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Clinical Evaluation of the crown using Modified Ryge Criteria

研究概览

简要总结

Fifty healthy cooperative children will be randomly allocated to two groups. Group I (test group) will receive CAD/CAM PEEK crowns, while group II (control group) will receive SSC. The crowns will be evaluated clinically and radiographically.

详细描述

A two-arm randomized controlled clinical trial. A total of 50 healthy children aged 5-7 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankl behavioral rating scale. Each child selected will have at least one mandibular second primary molar indicated for full coverage. Written informed consent will be obtained from their guardians. Participants will be randomly allocated into two groups according to the crown that will be used. Group I (test group) will receive CAD/CAM PEEK crowns, while group II (control group) will receive SSC. Using Modified Ryge's Criteria, the crowns will be examined clinically for anatomic form, restoration staining, marginal discoloration, colour match, surface roughness, marginal adaptation, proximal contact, occlusal wear of crown, wear of opposing tooth, and presence of cracks. Gingival and Plaques index scores will be recorded, as well as chairside time, patient and parental satisfaction. The patients will be recalled at 1 week then 3, 6 and 12 months for clinical follow-up. Radiographs will be taken at 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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Participant Inclusion Criteria
  • •Age ranges from 5 - 7 years.
  • •Children free of any systemic disease or special health care need (ASA I).(30)
  • •Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4) (Appendix I).(31)
  • •Patients whose parents will give their consent to participate.
  • •Tooth Inclusion Criteria
  • •Mandibular second primary molars that are indicated for full coverage:(7)
  • •Present opposing tooth.

排除标准

  • •Root resorption affecting more than one third of the root length.
  • •Clinical signs and symptoms of irreversible pulpitis or non-vitality. (Appendix II) (32)
  • •Fistula or abscess related to the selected tooth clinically and radiographically.
  • •Non restorable crowns.
  • •Signs of mobility or bone resorption.

研究组 & 干预措施

Stainless Steel Crowns

Active Comparator

干预措施: Full coverage Crowns (Procedure)

PEEK Crowns

Experimental

干预措施: Full coverage Crowns (Procedure)

结局指标

主要结局

Clinical Evaluation of the crown using Modified Ryge Criteria

时间窗: Day 0, 1 week , 3 months, 6 months , 12 months

次要结局

未报告次要终点

研究者

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

Rodaina Helmy

Assistant Lecturer, Pediatric dentistry department, Faculty of dentistry

Alexandria University

研究点 (2)

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