Clinical Applicability of PBSCIMMO as a Single Material in Endodontic Obturations
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Patients with necrotic teeth and periradicular lesion evaluated by cone beam tomography
研究概览
简要总结
A randomized, interventional, prospective, unicentric clinical study, 86 patients will be submitted to endodontic treatment of necrotic teeth. 43 patients will complete treatment with obturation with AHPlus cement and Gutta-Percha cones (group A) and 43 patients will complete treatment with PBS® CIMMO cement (single material) (group B). The primary outcome will be the repair of the periradicular lesion demonstrated by integrity of the hard blade throughout the perimeter of the root identified by Tomography Cone Beam, performed after 6 months of treatment. The secondary endpoint will be the absence of fistula after 6 months of treatment identified by clinical examination.
详细描述
GOALS PRIMARY OBJECTIVE-Evaluate the PBS CIMMO cement as a single element in endodontic obturations of necrotic teeth, through the analysis of integrity of the hard blade throughout the perimeter of the root of the treated tooth, identified by Tomography Cone Beam, after 6 months of treatment.
SECONDARY OBJECTIVE- Clinical evaluation of teeth treated after 6 months, with the purpose of identifying the absence of clinical signs and symptoms, through the finding of absence of fistula.
METHOD-DESIGN A randomized, interventional, prospective, unicentric, double blind clinical trial.
APPROVAL This work was approved by the Research Ethics Committee of the Vale do Sapucaí University (UNIVÁS) and is registered in the Brazilian Platform - Certificate of Approval for CAAE-number 77495717.7.0000.5102 CONSENT Relevant information from this study will be provided to all patients in an understandable way. Patients will have the opportunity to have their questions answered and will provide their consent by signing the free and informed consent form The study is being carried out in Brazil, in the urban area of the city of Pouso Alegre, state of Minas Geraes, in the Clinic of the Brazilian Association of Dentistry (ABO).
Interventions
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
- Single (Outcomes Assessor)
盲法说明
After 6 months the results will be evaluated by two independent professionals, who did not participate in the interventions and are not aware of the allocation. The evaluation will be performed by means of tomography and clinical examination
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presenting with a diagnosis of necrosis.
排除标准
- •Patients who drop out during the study
- •Patients who do not return to the final exam after 6 months.
- •Patients who present more than one tooth in need of treatment will choose only one tooth, the others will be excluded.
研究组 & 干预措施
GUTTA PERCHA and AHPLUS cement (group A)
43 patients will undergo endodontic treatment with obturation with AHPlus cement and Gutta-Percha cones. This treatment will be performed in 2 sessions. First intervention: endodontic instrumentation and introduction of intra-canal medication that will remain in the tooth for 4 weeks. Second intervention: removal of intracanal medication and filling with cement and gutta percha AHPlus.
干预措施: Gutta Percha and AHPLUS cement (group A) (Procedure)
PBS CIMMO cement (group B)
43 patients will undergo endodontic treatment with PBS CIMMO® cement (single material).This treatment will be performed in 1 session.Single intervention: endodontic instrumentation and cement filling PBS CIMMO.
干预措施: PBS CIMMO cement (group B) (Procedure)
结局指标
主要结局
Patients with necrotic teeth and periradicular lesion evaluated by cone beam tomography
时间窗: Patients will return six months after the procedure to undergo a exam cone Beam tomografy
The data will be aggregated by presence of hard blade that determines the phylogenetic parameter of success of the treatment. This physiological parameter is the presence of hard blade integrated in the tomography image, which will determine healthy periodontal ligament
次要结局
- Clinical examination of patients' treated teeth(Patients will return six months after the procedure to undergo a clinical examination)
研究者
Rubia Moura Leite Boczar
Principal investigator
Universidade do Vale do Sapucai