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临床试验/NCT04087226
NCT04087226已完成不适用

Comparative Evaluation of Gingival Displacement by Polytetrafluoroethylene (PTFE) & Conventional Retraction Cord- A Randomized Control Trial

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月1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
60
试验地点
1
主要终点
Difference between Mean Horizontal Gingival Displacement by PTFE retraction cord and Conventional retraction cord among sixty participants as assessed by Stereomicroscope.

研究概览

简要总结

To achieve harmony between restoration and surrounding periodontium, soft tissue management plays a pivotal role. Various Gingival displacement techniques show varying results in achieving the goals of displacement. The most preferred method of displacement by dental practitioners is through conventional retraction cord made up of cotton, which besides its advantages, poses certain drawbacks, including low tear strength, high friction, and fiber remnants within the sulcus.

Polytetrafluoroethylene (PTFE) retraction cord, is a fluoropolymer, known for its high tear strength, low friction, and bio-compatibility.

This study aims to determine the difference of horizontal gingival displacement between PTFE and conventional retraction cord.

Participants inducted in this study will be assessed for eligibility. qualifying subjects will receive crown preparation for Porcelain-fused to-metal crown. subjects will then be randomly allocated to either of the two arms of intervention. After making a pre-displacement impression, Retraction cord will be applied for 3 minutes, then removed to record post-displacement impression.

the difference in pre and post-displacement mean gingival sulcus width will be assessed by a stereomicroscope using image analysis software.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Indication of full veneer crown
  • •Age group: 18-60 years
  • •Probing Depth 2-3mm and no bleeding on probing
  • •No signs of gingival/periodontal disease

排除标准

  • •Indication of subgingival margin location
  • •Developmental anomaly (anatomical) affecting abutment tooth
  • •Bleeding disorder
  • •Pregnancy

研究组 & 干预措施

PTFE Retraction Cord

Experimental

干预措施: PTFE Retraction Cord (Device)

Conventional Retraction Cord

Active Comparator

干预措施: PTFE Retraction Cord (Device)

结局指标

主要结局

Difference between Mean Horizontal Gingival Displacement by PTFE retraction cord and Conventional retraction cord among sixty participants as assessed by Stereomicroscope.

时间窗: 3 minutes after displacement

次要结局

  • Difference between Post-displacement Bleeding by PTFE and conventional retraction cord among sixty participants by visual assessment(immediately after cord removal)
  • Difference between ease of Application of PTFE and conventional retraction cord among sixty participants.(immediately after cord removal)

研究者

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

Humera Nasim

Principal Investigator

Dow University of Health Sciences

研究点 (1)

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