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临床试验/NCT06592079
NCT06592079尚未招募不适用

Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 34 人开始时间: 2024年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
34
主要终点
Volumetric Analysis of Mid-facial recession

研究概览

简要总结

Evaluation of soft and hard tissue changes after immediate implant placement with connective tissue graft and bone as a control group and connective tissue graft only as a test group.

详细描述

This randomized clinical trial will evaluate the effect of using connective tissue graft and bone graft versus connective tissue graft, with customized healing abutments during immediate implant placement on volumetric mid facial recession .In patients with type I socket who need extraction in the anterior maxilla.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient-related criteria:
  • Adults at or above the age of
  • Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
  • The failing tooth will have adjacent and opposing natural teeth.
  • Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
  • Able to tolerate surgical periodontal procedures.
  • Full mouth plaque and bleeding scores less than 20%.
  • Compliance with the maintenance program.
  • Provide informed consent.
  • Accepts the one-year follow-up period.
  • Teeth related criteria:
  • Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
  • Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
  • Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm

排除标准

  • Patients diagnosed with periodontal diseases.
  • Current or previous smokers.
  • Pregnant and lactating females.
  • Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
  • Patients with active infection related at the site of implant/bone graft placement.
  • Patients with parafunctional habits

结局指标

主要结局

Volumetric Analysis of Mid-facial recession

时间窗: Preoperative,3months,6months and 12 months

3d viewer will be used to the the midfacial recession .

次要结局

  • Volumetric analysis of Interdental papillae height(Preoperative , 3 months, 6 months and 12 months)
  • Bone formed labial to the implant(Preoperative and 1 year)
  • Horizontal labio-palatal bone collapse((Preoperative and 1 year))
  • Vertical crestal bone level changes(Preoperative and 1 year)
  • Gingival biotype(Preoperative, 6 months and 12 months)
  • Volumetric analysis of buccal contour(Preoperative,3months,6months and 12 months)
  • Full mouth bleeding score (FMBS)(Preoperative, 6months and 12 months)
  • Pain and discomfort(At 1,3 and 7 days after the surgery)
  • Full mouth plaque score (FMPS)(Preoperative, 6 months and 12 months)
  • Pink Esthetic Score(at 12 months)

研究者

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

Norai Ahmed Mohamed Zayed

Assistant Lecturer

Cairo University

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