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临床试验/NCT03784430
NCT03784430已完成不适用

Soft and Hard Tissue Changes After Immediate Single-tooth Replacement With or Without a Submarginal Connective Tissue Graft

Università Vita-Salute San Raffaele1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年10月3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
30
试验地点
1
主要终点
Volumetric buccal bone changes

研究概览

简要总结

A recent systematic review (Lee et al, 2016) reported that placement of a soft tissue graft concurrent with immediate implantation may contribute to the stability of gingival level and the augmentation of soft tissue contour. However, most included studies did not have a control group to directly demonstrate the benefit of an immediate implant combined with soft tissue graft (IMITG) compared to immediate implant alone.The objective of this randomized controlled clinical trial with a parallel design is to evaluate the influence of the connective tissue graft on the buccal bone alterations after tooth extraction and immediate implant placement by means of cone beam computer tomography (CBCT).

详细描述

All participants will be selected on a consecutive basis, among individuals, above the age of 18 years, referred to Dental Clinic of the San Raffaele University, with a single failing tooth in the upper and lower jaw from second premolar to second premolar, candidates for a single implant restoration. After local anesthesia, a split-full-split thickness envelope flap, as described for the treatment of multiple gingival recessions by Zucchelli and de Sanctis (2000), will be elevated and the tooth will be extracted a-traumatically. The immediate implantation procedure will be carried out according to the manufacture protocol and 1mm of the transmucosal portion of the implant will be positioned under the buccal bone crest. In the group "Implant+CTG" a connective tissue graft (CTG), resulting from the extraoral de-epithelialization with the knife blade of a free gingival graft harvested from the palate, will be anchored at the anatomic papillae with 2 horizontal mattress sutures and positioned 1 mm coronal to the buccal bone crest and in the apical direction 2 mm above the buccal crest. Patients will be followed for 6 months after implant placement and 6 months after loading.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •a single tooth to be extracted for endodontic failure, fractures, root caries or resorption in the maxillary and mandibular area from second premolar to second premolar
  • •patient in good systemic health, with no contraindication for oral surgical interventions

排除标准

  • •patients with impaired systemic diseases that will interfere with surgical interventions (autoimmune diseases, uncontrolled diabetes)
  • •assumption of bisphosphonate
  • •smoking more than 10 cigarettes a day

研究组 & 干预措施

Implant

Active Comparator

Immediate dental implant placement

干预措施: Immediate dental implant placement (Procedure)

Implant+CTG

Experimental

Immediate dental implant placement with CTG.

干预措施: Immediate dental implant placement with CTG (Procedure)

结局指标

主要结局

Volumetric buccal bone changes

时间窗: 6 months

Ratio scale - lower values represent a better outcome

次要结局

  • Buccal soft tissue changes(6 months)
  • Patient perception outcomes(1 week and 6 months)
  • Volumetric buccal soft tissue changes(6 months)

研究者

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

Massimo de Sanctis

Prof.

Università Vita-Salute San Raffaele

研究点 (1)

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