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临床试验/NCT03548896
NCT03548896Unknown不适用

Dimensional Changes Following Ridge Augmentation of the Buccal Wall in Dehiscence Sockets: a Randomized-controlled Clinical Trial.

Universitat Internacional de Catalunya1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年2月1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
24
试验地点
1
主要终点
total width of the buccolingual bone

研究概览

简要总结

There is limited data regarding socket preservation in three wall defects and no enough evidence of implant placement in previously regenerated area with allograft.

The aim of this randomized controlled clinical trial is to analyze and compare dimensional changes in extractions sites with buccal bone defects > 5 mm left untreated (simultaneous regeneration during implant placement) or treated using a mineralized allograft.

详细描述

  1. Introduction:

The alveolar process is tooth dependent and once a single tooth is extracted, the architecture of the socket undergoes dimensional changes hindering the prosthetic rehabilitation at the edentulous crest which demands a posterior guided bone regeneration (GBR). Studies in dogs described the main changes happened after tooth extraction (1,2); the blood forms a clot at the wound site which is replaced by a connective tissue matrix: after 1 month the woven bone fills the extraction socket; subsequently the woven bone undergoes osteoclastic resorption which leads to a maturation of the recently formed bone, gradually replaced with lamellar and bone marrow. Such events were clinically evaluated in several studies with an average of loss in width (3.5-4mm) (3). Bone resorption in height is correlated to the plate thickness; thin-wall phenotypes (<1mm) have a median vertical bone loss of 7.5mm in the central risk zone (4). Moreover, at the aesthetic zone, this narrow crest makes more difficult the adequate implant placement (5), then functional and esthetic complications can be expected.

The fresh socket in the esthetic zone represents a challenge for the clinician and immediate implant placement (type I) is associated with a high risk of mucosal

recessions. Moreover, the absence of the buccal plate increases the risk (6). Early implant placement (type II) described by Buser et al. (7) reported long term excellent esthetic results and this technique is compatible with alveolar ridge preservation.

Alveolar ridge preservation is a widely used technique immediately after tooth extraction to minimize the alveolar resorption, to accelerate the bone formation and to improve the prosthetic restoration with an implant placed on a tridimensional way. Different biomaterials were used: autografts (8), allografts (9), xenografts (10,11), alloplasts (11,12) with or without barrier membranes. In all of them, less bone resorption was drawn with respect to natural healing; however, such techniques do not prevent physiologic bone resorption but limit it, improving the expected results in absence of preservation (13). Comparing the healing time with different biomaterials, mineralized bone allograft demonstrated similar results in the amount of new bone growth at 3 and 6 months after extraction (14) allowing the reentry before.

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 (Investigator, 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
否

入选标准

  • •Men and women over 18 years old.
  • •Patients requiring single tooth extraction with partial or total absence of the buccal bone wall that will be defined as loss of more than 5 mm with respect to the supposed location of the bone crest (23).
  • •Presence of adjacent teeth.
  • •Anterior teeth (from second premolar to second premolar) of the maxilla.
  • •Patients who had requested an implant restoration between adjacent teeth
  • •Absence of active periodontal disease.
  • •Good level of oral hygiene (Plaque Index < 25%; (27).
  • •Absence of systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes mellitus, osteoporosis, biphosphonate medication).
  • •Non-smokers or light smokers (< 10 cigarettes per day).
  • •Written informed consent signed.

排除标准

  • •Buccal soft tissue recession.
  • •Acute infection at the extraction site.
  • •Presence of adjacent implants.
  • •Absence of any adjacent tooth
  • •Long-term non-steroidal anti-inflammatory drug therapy (3 months).
  • •Lactating females or currently pregnancy.
  • •Severe cognitive or psychiatric disorders.
  • •Unwillingness to return for follow-up examination.

研究组 & 干预措施

Dental Implants

Experimental

Dental implants Titanium SLA treated surface of different dimensions according to the specific needs of the patient

干预措施: Post extraction socket (Procedure)

Resorbable membrane

Experimental

Resorbable membrane Cross link collagen membrane from porcine animal with a measure of 15 x 25 mm

干预措施: Post extraction socket (Procedure)

Allograft

Experimental

Allograft Bone from human source that is administered in a dosage of 1 cc per patient

干预措施: Post extraction socket (Procedure)

结局指标

主要结局

total width of the buccolingual bone

时间窗: Baseline, 3 months, 1 year

to evaluate the bone changes in cone beam computed tomography

次要结局

  • pink esthetic score(Baseline, 3 months and at 1 year)
  • keratinized tissue(Baseline, 3 months and at 1 year)
  • soft tissue level(Baseline, 3 months and at 1 year)
  • volumetric soft tissue changes (linear measurement)(At 3 months and at 1 year)
  • radiographic bone loss (in millimeters)(At 3 months, and at 1 year)

研究者

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

Pedro Diz Iglesias

Principal investigator

Universitat Internacional de Catalunya

研究点 (1)

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