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临床试验/NCT03200938
NCT03200938已完成不适用

Clinical Applicability of PBS® CIMMO Cement in Decoded Teeth Pulpotomies as Base and Restoration

Universidade do Vale do Sapucai4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
4
主要终点
Clinical examination evaluate the repair capacity of PBS® CIMMO and Zinc Oxide cements in pulpotomies will be evaluated.

研究概览

简要总结

Randomized clinical study in pulpotomies of deciduous molar teeth. A comparison of two techniques is established.

详细描述

This is a randomized controlled clinical trial conducted at the Universidade do Vale do Sapucaí (UNIVAS), Pouso Alegre, Minas Gerais and the University of Vale do Rio Verde (UNINCOR) Três Corações, Minas Gerais. A project will be submitted to the Brazil Platform to UNIVÁS and UNINCOR ethics committees. Thirty children aged four to ten years old will be selected from the Pediatric Dentistry Clinic of the College of Dentistry of the Vale do Rio Verde Três Corações University. The sample will consist of 30 primary molars that show indication for pulpotomy. The inclusion criteria of the teeth to be selected are: absence of spontaneous painful symptomatology in the preoperative period, evidence of live red bleeding, cut resistance, associated with hemostasis after exposure of the pulp tissue. Radiographically, the teeth should present 2/3 of the root length, absence of radiolucent inter-radicular lesion and internal root resorption.

The technique recommended will be in a single session. Local anesthesia with 1: 100,000 articaine (DFL®) will be used a tube containing 1.8 ml. Absolute insulation with clamp 14 (IVORY®), rubber sheet (Madeitex®) and arch (JON®). The opening will be performed with a 1016 HL (KG®) drill and a dentin curette (Duflex®). All carious tissue and the coronary pulp will be removed with abundant irrigation.

In group A (control) the irrigation will be with physiological saline and then it will be applied in the pulp chamber with autoclaved cotton ball, formocresol for five minutes. Subsequently, calcium hydroxide cement base (Hidro C®), zinc oxide cement base and eugenol (IRM®) and restoration of the final tooth with composite resin will be inserted.

In group B the irrigation will be with sterile distilled water (the cement to be used loses its properties in front of the saline solution). Excess blood and distilled water from the irrigation will be sucked through disposable endodontic cannula (DFL®) and the fast trapped PBS®CIMMO cement will be handled through sterile glass plate and spatula 24 (Duflex®). Then it will be taken to the humid chamber with cement door, old amalgam (Duflex®) and condenser with Schilder condenser number 5 (Odus®). The cement will serve as a sub-base, base and final restoration.

Patients will be submitted to final radiographs and receive systemic medication with analgesic and anti-inflammatory. The evaluations will be carried out in 6 months and will be through clinical and radiographic examinations, to define the result of the treatments. Clinical examinations will be performed under artificial light through an exploratory probe (Duflex®) and clinical mirror (Duflex®). The clinical criteria to be observed are: edema, mobility, fistula and pain. The radiographic evaluations will be through periapical radiography with the aid of a radial ortho positioner (DFL®). In the radiographs will be observed the presence or absence of internal and external resorptions, as well as presence or absence of inter-radicular lesion.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Blind study, the patient is masked

入排标准

年龄范围
3 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Teeth exhibiting caries exposure
  • Teeth with incomplete rhizogenesis
  • Absence of periradicular lesion and fistula
  • Accidental pulp exposure

排除标准

  • Teeth with spontaneous pain
  • Teeth With impossibility to perform absolute isolation
  • Teeth with mobility, presence of fistula and root resorption of more than two-thirds of the root
  • Teeth unable to be restored
  • Teeth with painful response after vertical percussion

结局指标

主要结局

Clinical examination evaluate the repair capacity of PBS® CIMMO and Zinc Oxide cements in pulpotomies will be evaluated.

时间窗: 12 months

The restorative capacity of the PBS CIMMO and Zinc Oxide cements will be assessed by clinical and radiographic examination six months after the pulpotomies.

次要结局

  • Radiografhic examination evaluate the repair capacity of PBS CIMMO and Zinc Oxide(12 months)

研究者

发起方
Universidade do Vale do Sapucai
申办方类型
Other
责任方
Principal Investigator
主要研究者

José Dias da Silva Neto

Clinical Professor, Principal Investigator

Universidade do Vale do Sapucai

研究点 (4)

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