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临床试验/NCT04101552
NCT04101552Unknown不适用

Clinical and Radiographic Assessment of Immediate Implant Placement in Maxillary Esthetic Zone Using Socket Shield Technique With and Without the Use of Xenograft Particulate Graft Material

Cairo University0 个研究点目标入组 10 人开始时间: 2019年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
主要终点
Marginal bone loss

研究概览

简要总结

Many techniques have been proposed to prevent or rather minimize the labial bone resorption following extraction including guided bone regeneration techniques that has been attempted for many years now to preserve the alveolar ridge dimensions .

Immediate implant placement, flapless implant placement, palataly positioned implants and even platform switching.

However none of these methods were able to completely preserve the coronal part of the facial bone wall, and since the main reason of bone loss following extraction is the loss of the periodontal ligament, it seemed logical that root retention may affect the resorption process,The reason the root retention technique works in its different applications is due to the maintenance of the periodontal attachment including cementum, periodontal ligaments and bundle bone, this principle was used by Hurzeler in 2010 in a technique called socket shied technique.

详细描述

  • The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group conventional immediate implant placement with immediate temporization and study group socket shield technique with immediate temporization.
  • Patients of both groups will be subjected to CBCT (diagnostic for upper arch).
  • Intra operative procedures (for both groups) followed by CBCT will be taken for every patient
  • Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine)
  • Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
  • In the study group: along surgical fissure bur will be used for hemisectioning.
  • The palatal portion will be carefully separated and extracted by a periotome and forceps.
  • The osteomy site will be inspected and cleaned from any granulation tissue and the implant will be placed palatal to the tooth fragment.
  • The jump gap was grafted with a xenogeneic bone particulate (De-proteinized bovine bone mineral Small granules (0.25-1 mm), the implant gained primary stability from bone apical and palatal sufficient to immediately restore with provisional restoration.
  • In the control group: the root was hemisected using a fissure bur in a mesio-distal direction, and a traumatic removal of the palatal fragment of the root was achieved (no pressure was applied on it), then the buccal fragment was reduced using surgical bur leaving a thin layer of the root aspect intact to the buccal plate of the bone.
  • The implant is placed in the socket in a way leaving space away from the remaining buccal plate without grafting this jumping gap
  • The provisional restorations were relieved of occlusal contacts in centric occlusion and excursive movements. These restorations remained in situ for at least 6 to 12 weeks prior to any modifications or commencement of definitive restorative therapy
  • A soft diet was recommended for the duration of the implant-healing phase. The patient was advised against functioning or activities to the implant site.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
  • Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement

排除标准

  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Uncontrolled diabetic patients.
  • Pregnant patients.
  • Teeth with Large pulpal pathosis as cysts, large periapical granulomas
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
  • Immunodeficiency pathology, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
  • Psychiatric problems.

研究组 & 干预措施

grafted versus graft less socket shield technique

Experimental

干预措施: socket shield technique with xenophobic graft particulate and without the use of graft (Procedure)

结局指标

主要结局

Marginal bone loss

时间窗: • Amount of bone loss will be measured after 6 month using linear measurement from CBCT

Will be measured using linear measurements from CBCT

次要结局

  • secondary stability(will be measured intraoperative and 3 months after surgery)

研究者

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

Poosy Hany Zaki Mohamed

principal investigator

Cairo University

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