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临床试验/NCT05458583
NCT05458583已完成不适用

Comparison of Periodontal Status and Failure Rates With Different Retainer Bonding Methods and Adhesives: A Randomized Clinical Trial

Pamukkale University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月3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
100
试验地点
2
主要终点
Plaque index measurements

研究概览

简要总结

The aim of this study was to evaluate fixed retainers, bonded with either direct or indirect techniques using one- or two-step adhesives, in terms of periodontal status and failure rates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The investigator who performed the assessment of the periodontal status was blinded to study groups. Moreover, the person performing data entry and the statistician was blinded to the study groups.

入排标准

性别
All
接受健康志愿者

入选标准

  • Good treatment outcomes
  • good oral hygiene
  • No systemic or periodontal problems
  • No extraction or missing anterior teeth and restorations

排除标准

  • Patients unwilling to wear a fixed retainer

结局指标

主要结局

Plaque index measurements

时间窗: 12 months (T2) after bonding

Plaque index was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at 12 months after bonding based on the following scale: 0 (no plaque), 1 (a film of plaque adhering to the free gingival margin and adjacent area of the tooth), 2 (moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin which can be seen with the naked eye) and 3 (abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin). All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL).

Gingival index measurements

时间窗: 12 months (T2) after bonding

Gingival index was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at 12 months after bonding based on the following scale: 0 (absence of inflammation), 1 (mild inflammation), 2 (moderate inflammation) and 3 (severe inflammation). All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL).

Calculus index measurements

时间窗: 12 months after bonding

Calculus index was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at 12 months after bonding based on the following scale: 0 (no calculus present), 1 (supragingival calculus covering not more than one third of the exposed tooth surface), 2 (supragingival calculus covering more than one third but not more than two thirds of the exposed tooth surface or the presence of individual flecks of subgingival calculus around the cervical portion of the tooth or both) and 3 (supragingival calculus covering more than two thirds of the exposed tooth surface or a continuous heavy band of subgingival calculus around the cervical portion of the tooth or both). All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL)

次要结局

  • Failure rate(during 1-year follow-up)

研究者

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

Serpil Cokakoglu

Assistant Professor

Pamukkale University

研究点 (2)

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