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临床试验/NCT07041879
NCT07041879进行中(未招募)不适用

Piezotome Atraumatic Tooth Extraction And Immediate Implant Placement In Maxillary Anterior Region: Randomized Clinical Trial

Alexandria University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024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
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Radiographic assessment of the management of the crestal bone width and changes in labial bone thickness.

研究概览

简要总结

Tooth extraction is critical for dental treatment complications followed by immediate implant placement to restore the extracted tooth . The use of devices or instruments such as piezotome and periotome as aids in atraumatic surgical proceduresو conserving both bone and soft tissue, allowing extraction without unnecessary socket expansion. Immediate implant placement into fresh extraction sockets offers some esthetic and functional advantages.

the Aim of this study is to compare and evaluate the effectiveness of the piezotome and periotome as aids for atraumatic extraction in immediate implant placement in maxillary anterior teeth.

详细描述

30 patients with non-restorable maxillary anterior teeth will be included. Teeth will be extracted using an atraumatic tooth extraction using piezotome and periotome as aids in atraumatic surgical procedures. After that an immediate implant will be placed into the fresh extraction socket . patients will be recalled for follow-up 3months after implant placement to evaluate pain by VAS and evaluate bone healing using CBCT.

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)

盲法说明

Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator

入排标准

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

入选标准

  • •Patients of both gender with a non-restorable maxillary anterior tooth in the aesthetic zone indicated for extraction and subsequent immediate implant placement. Including those with:
  • •Severely carious tooth that it cannot be restored.
  • •Pulpal necrosis or irreversible pulpitis that is not amenable to endodontics.
  • •Periodontally involved Tooth with grade 2 mobility or above.
  • •Tooth with root caries that can't be restored.
  • •Patients with extraction socket Type I, according to Elian's classification

排除标准

  • •Patients with extraction socket Type II or III, with defect in the buccal plate
  • •Patients with deciduous teeth.
  • •Heavy smokers.
  • •Medically compromised patients with conditions that would impede implant osteointegration and healing.

研究组 & 干预措施

Atraumatic extraction with piezotome and subsequently immediate implant placement

Active Comparator

Patients with maxillary anterior teeth will be atraumatically extracted with piezotome extraction, and subsequently immediate implant placement

干预措施: maxillary anterior teeth atraumatically extracted with piezotome extraction kit, and subsequent immediate implant placement (Procedure)

Atraumatic extraction with periotome and subsequently immediate implant placement

Experimental

Patients with maxillary anterior teeth will be atraumatically extracted with periotome, and subsequently immediate implant placement

干预措施: maxillary anterior teeth atraumatically extracted with periotome, and subsequent immediate implant placment (Procedure)

结局指标

主要结局

Radiographic assessment of the management of the crestal bone width and changes in labial bone thickness.

时间窗: 5 months

A postoperative CBCT will be taken within 24 hours of implant placement followed by a 6-months scan, and values will be compared with the preoperative record. The assessment will be conducted using the tools on the "On Demand 3D App." Software\*. The following criteria will be assessed:

次要结局

  • Clinical Wound Healing(21 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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