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临床试验/NCT07748494
NCT07748494已完成不适用

Socket Sealing Abutment in Immediate Molar Implant Placement With or Without Grafting Material

Mansoura University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年2月15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
32
试验地点
1
主要终点
soft tissue changes

研究概览

简要总结

This study aimed to evaluate bone and soft tissue changes clinically and radio-graphically after using socket sealing abutment with or without bone graft material.

详细描述

Immediate implant placement in molar extraction sockets poses challenges related to soft-tissue closure, jumping distance, and peri-implant tissue stability. Socket sealing abutments (SSA) have recently been introduced to enhance soft-tissue healing and maintain peri-implant architecture, with or without adjunctive bone grafting.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with non-restorable maxillary or mandibular molars indicated for extraction and replacement with implants
  • Age between 18-45 years
  • Sufficient inter-arch space to accommodate the future prosthesis
  • Good oral hygiene
  • Free from systemic diseases
  • Patients with jumping space > 2 mm

排除标准

  • Presence of any pathological lesion or root tips at the planned surgical site
  • Aggressive periodontal disease
  • Inadequate bone height or thickness for implant placement
  • Alcohol or drug abuse
  • Systemic diseases that contraindicate implant placement (e.g., osteoporosis, active cancer)
  • Pregnancy
  • Para-functional habits (e.g., bruxism, clenching)
  • Patients wearing orthodontic appliances

研究组 & 干预措施

Without Grafting Material

Active Comparator

Placement of immediate molar implant followed by socket sealing abutment without adding grafting material.

干预措施: Immediate Molar Implant Placement without Grafting Material (Procedure)

With Grafting Material

Experimental

Placement of immediate molar implant followed by socket sealing abutment and addition of grafting material to the extraction socket.

干预措施: Immediate Molar Implant Placement with Grafting Material (Procedure)

结局指标

主要结局

soft tissue changes

时间窗: Baseline,3 month,6month

Optical scans of the patients' impressions were obtained immediately after surgery (baseline) and at 3- and 6-month follow-up intervals. For each patient, the baseline STL file was digitally superimposed onto the corresponding 3- and 6-month STL files using dedicated image analysis software to evaluate changes in the peri-implant soft tissues over time. A standardized two-dimensional bucco-lingual cross-sectional image was generated along the long axis of the implant. Buccal and lingual/palatal soft tissue dimensional changes were assessed by measuring the linear distance between baseline and follow-up(3,6month) soft tissue profiles at 1, 2, 3, and 4 mm apical to the GM. Mid-buccal gingival recession was evaluated by measuring the vertical change in the position of the gingival margin at 3,6month.

次要结局

  • Dental implant stability assessed by resonance frequency analysis (ISQ)(basline 3,6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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