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临床试验/NCT03581565
NCT03581565已完成不适用

Effect of Cementation Technique Applied for Single-tooth Implant Crowns on Residual Cement: A Three-arm Parallel-group Randomized Clinical Trial

Kıvanç Akça2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年10月16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
发起方
入组人数
10
试验地点
2
主要终点
visual assessment of residual cement on crown-abutment complex

研究概览

简要总结

Cement retention has been widely used for implant-supported fixed partial dentures in daily dental practice. The cementation approach indeed offers straightforward clinical application protocol which is basically conceptualized for tooth/teeth supported fixed restorations. However, removal of excess cement around implant restorations presents specific difficulties. More importantly, there are certain biological consequences due to residual cement leftover in peri-implant sulcus. There is no evidence based guidance with regards to cementation techniques applied for implant supported fixed restorations due to limited clinical studies. Therefore the aim of this clinical trial is to compare three different cementation technique with regards to removal of excess cement and other clinical subsidiaries (abutment margin, crown surface and contour) involving indirectly as well.

详细描述

Single-tooth implant crowns to replace missing molar tooth were addressed to qualify and quantify residual cement on implant-abutment complex and peri-implant soft tissue following cementation. Thirty bone-level dental implants of one kind enrolled in the study. Prior to delivery of screw-retained crowns completed for usual treatment, implants were allocated randomly to a trial comparison group. Three different cement loading approach, ten in each group, was applied using cement-retained trial crowns on prefabricated metal abutments. Following completion of the assigned cementation technique, the trial crown was removed with its abutment accessing from the occlusal hole prepared after removal of excess cement. Then, the presence of residual cement on implant-abutment complex and implant soft tissue in accordance with axial and proximal surfaces was qualified. To quantify the amount of residual cement in accordance with location and distribution, the crown-abutment complex was digitized three-dimensionally using an intra-oral scanner. The output of surface data was evaluated in virtual 3-D image for cement excess, when detected location in the abutment-crown complex is recorded, area and distribution was calculated using a software. The frequency of occurrence and quantity of residual cement of 3-different cementation techniques was statistically evaluated using logistic and linear regression model separately considering abutment margin, crown surface and contour.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • completed growth and development
  • periodontally and dentally healthy conditions
  • missing single molar tooth without free-end edentulism
  • bone-level standard diameter of a specific implant from one manufacturer
  • complication free healing period for osseointegration following straightforward surgical implant placement
  • natural dentition or fixed restoration in dental arch
  • signing of informed consent form

排除标准

  • absolute systemic contraindications for implant surgery (e.g. bone cancer, radiation therapy)
  • relative systemic contraindications for implant surgery (e.g. diabetes, steroid therapy)
  • risk factors (e.g. smoking, limited mouth opening)

研究组 & 干预措施

Technique I

Active Comparator

Loading of a zinc polycarboxylate (with the requirements of ISO 9917) cement to fulfill the crown

Cement: Poly-F, DentsplySirona, York, Pennsylvania, United States Mixing Ratio: 1 scoop powder: 2 drops liquid Mixing Time (extraoral): 30 seconds Working Time (extraoral): 45 seconds Application (extraoral): placement of mixture into crown using a heidemann Spatula Setting Time (intraoral): 2-8 minutes

干预措施: zinc polycarboxylate (with the requirements of ISO 9917) (Other)

Technique II

Active Comparator

Loading of a zinc polycarboxylate (with the requirements of ISO 9917) to fill the coronal half of the crown

Cement: Poly-F, DentsplySirona, York, Pennsylvania, United States Mixing Ratio: 1 scoop powder: 2 drops liquid Mixing Time (extraoral): 30 seconds Working Time (extraoral): 45 seconds Application (extraoral): placement of mixture into crown using a heidemann Spatula Setting Time (intraoral): 2-8 minutes

干预措施: zinc polycarboxylate (with the requirements of ISO 9917) (Other)

Technique III

Active Comparator

Application of a zinc polycarboxylate (with the requirements of ISO 9917) to the axial walls of internal surface of crown

Cement: Poly-F, DentsplySirona, York, Pennsylvania, United States Mixing Ratio: 1 scoop powder: 2 drops liquid Mixing Time (extraoral): 30 seconds Working Time (extraoral): 45 seconds Application (extraoral): application of mixture into crown using a bonding applicator tip Setting Time (intraoral): 2-8 minutes

干预措施: zinc polycarboxylate (with the requirements of ISO 9917) (Other)

结局指标

主要结局

visual assessment of residual cement on crown-abutment complex

时间窗: 15 minutes

removal of cemented crown-abutment complex to detect excess cement on the mesial, distal, buccal and lingual surfaces of crown and abutment separately scoring: presence or absence

measurement of residual cement area and distribution

时间窗: 30 minutes

digitalization of the removed crown-abutment complexes those scored with cement presence, then using a software, virtual selection of existing cement to calculate the area in millimeter square and to define the direction and the extension in millimeters on the mesial, distal, buccal and lingual surfaces of crown and abutment separately

次要结局

  • visual assessment of residual cement around the peri-implant soft tissue(15 minutes)

研究者

发起方
Kıvanç Akça
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kıvanç Akça

Prof. Dr.

Hacettepe University

研究点 (2)

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