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临床试验/NCT06558747
NCT06558747已完成不适用

Comparison of the Clinical Success of Pediatric Zirconia Crowns Applied with Different Luting Cements

Akdeniz University2 个研究点 分布在 2 个国家目标入组 53 人开始时间: 2017年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Retention Status

研究概览

简要总结

This randomized controlled trial aims to evaluate and compare the clinical outcomes of prefabricated zirconia crowns (PZCs) for primary molars cemented with different luting cements. The main questions to answer are:

Will there be any difference in the clinical success regarding retention among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding periodontal health among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding pulpal survival among the PZCs cemented with different luting cements? Fifty-three children (60 teeth), between 5 and 11 years old enrolled for the study. Researchers will compare the retention status, plaque index (PI), gingival index (GI), and probing depth (PD) scores, and endodontic/periodontal pathology of PZCs.

Participants will:

  • visit the clinic 1st,3rd,6th,12th months after the restoration.

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 (Participant)

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • no history of allergies
  • a Frankl scale score of 3 or 4
  • has at least one carious primary molar
  • No percussion or palpation sensitivity
  • No pathological root resorption
  • No abscess and/or fistula
  • No radiolucency at the furcation area
  • No prior pulpal treatment
  • Presence of permanent successor
  • No mobility or periodontal disease
  • Normal position of permanent successor
  • An interproximal decay and/or extensive decay with at least 2 surfaces
  • If present, physiological root resorption no more than one-third of the root
  • Opposing teeth in occlusal contact
  • Normal lamina dura and periodontal space

排除标准

  • congenital and/or developmental defects
  • history of bruxism
  • skeletal and/or dental malocclusion
  • history of trauma
  • infraocclusion

结局指标

主要结局

Retention Status

时间窗: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.

The clinical success of the crowns regarding the retention status was evaluated as either present or absent based on whether the crown remained on the restored tooth at each follow-up appointment. Crowns that were still in place during the follow-up visit were considered successful in terms of retention, while those that had decemented were considered unsuccessful.

次要结局

  • Gingival Index(Evaluations were conducted at the 1st, 3rd, 6th, 12th months.)
  • Pulpal Survival(Evaluations were conducted at the 1st, 3rd, 6th, 12th months.)
  • Plaque Index(Evaluations were conducted at the 1st, 3rd, 6th, 12th months.)
  • Probing Depth(Evaluations were conducted at the 1st, 3rd, 6th, 12th months.)

研究者

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

Hüseyin Karayılmaz

Proffessor at Pediatric Dentistry

Akdeniz University

研究点 (2)

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