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临床试验/NCT03334461
NCT03334461已完成2 期

Immunological and Regenerative Implications of Corrosion of Dental Materials in Children and Adolescents

University of Rijeka2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
2
主要终点
Reaction of oral bacterial flora to oral antiseptics and dental remineralisation agents

研究概览

简要总结

During orthodontic treatment intraoral corrosion results with release of nickel and titanium ions from orthodontic appliances in surrounding tissues. Those transported in the saliva and blood may cause a series of side effects from hypersensitivity reactions and soft tissue proliferation to cyto and genotoxicity. Nickel is one of the strongest contact allergens, present in numerous dental alloys. The aim of this project is to investigate the immune potential of nickel and titan ions (development of allergies, changes in cariogenic potential of dental plaque, resistance of gingivitis to therapy, and bacterial resistance to antibiotics) and changes in performance of orthodontic appliances with repercussion on regeneration of bone and periodontal tissues.

详细描述

Tooth movement with appliances based on nickel and titanium has got great osteogenic potential and can regenerate deficient parts of alveolar bone and gingiva and rehabilitate compromised occlusal relations and a patient's masticatory function. Due to the extended duration of this therapy, different procedures are carried out and materials are applied for prevention and regeneration of damaged enamel and oral mucosa. The oral cavity may be considered a galvanic cell in which dental alloys act as electrodes, while saliva and oral preventive and regenerative agents act as electrolites. The interaction causes corrosion, reduction of elasticity and increase of stiffness of appliances, which may in turn result in excessive forces, a disruption of tissue regeneration and irreparable damage of tooth roots, surrounding alveolar bone, periodontal ligament, gingiva and pulp.

During the extended exposion, released corrosive products in surrounding tissues and those transported in saliva and blood may cause a series of side effects from hypersensitivity reactions and soft tissue proliferation to cyto and genotoxicity. Today, allergies are ever more frequent and arise earlier in life. A specific group are children and young adolescents in pubertal growth, a period in which the immune system develops. Nickel is one of the strongest contact allergens, present in numerous dental alloys. Nickel allergy is occurs in up to 28.5% of population and cannot be deemed as low potential risk anymore.

In contrast, titan was considered a biocompatible material of no allergic potential. However, there is an increase in the frequency of presentations of different hypersensitivity reactions to titan, especially in patients with pacemakers. Numerous patients with hip endoprostheses, stents, dental implans and orthodontic appliances are exposed to titan. Titan allergy may be the cause of unexplained cases of failure and rejection of dental implants. Nickel and titan could cause bacterial resistance to antibiotics which may complicate treatment of a series of infections that are more frequent in children and adolescents.

Regulations for safety of medical products regulate safety issues of materials through mandatory laboratory testing and expertise. However, the testing of interactions of these materials with newly formed materials for prevention of damage and regeneration of orodental tissues is not obligatory prior to the start of their commercial use. Such testing should be conducted by independent scientific insitutions and not by producers with direct commercial interest.

The aim of this project is to investigate:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Unlabeled bottles containing testing agent

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with fixed orthodontic appliances
  • must be able to do a mouthwash

排除标准

  • patients allergic to fluoride agents and chlorhexidine gluconate

结局指标

主要结局

Reaction of oral bacterial flora to oral antiseptics and dental remineralisation agents

时间窗: 30 days

Detection of change of count of Streptococcus mutans, sorbinus and salivarius and total bacterial count assesed by qPCR in the dental plaque before and after intervention in patients with fixed orthodontic appliances.

次要结局

  • Friction of dental alloy(90 days)
  • Forces produced by dental alloy(90 days)
  • Dental arch shape(90 days)
  • Oral hygiene(210 days)
  • Gingivitis(210 days)
  • Corrosion of dental alloy(90 days)
  • Hardness of dental alloy(90 days)
  • pH of dental biofilm(210 days)
  • Surface roughness of dental alloy(90 days)
  • Stifness of dental alloy(90 days)
  • Elasticity of dental alloy(90 days)

研究者

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

Stjepan Spalj

Full Professor

University of Rijeka

研究点 (2)

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