PBS CIMMO DTA® Cement in Post-operative Sensitivity: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Assessment of postoperative sensitivity in posterior teeth: before the procedure, 48 hours later, 7; 15 and 30 days later. Thermal test.
研究概览
简要总结
Context: CEMENT PBS CIMMO DTA® has physical and biological properties that classify it as a biocompatible material and inducer of biomineralization, attributes that qualify it as material as an indirect pulp capper in permanent tooth restorations. Objective: The present clinical study proposes the use of PBS CIMMO DTA® cement as an indirect pulp capper, in resin restorations composed of permanent molars and premolars. The objective was to minimize postoperative sensitivity arising from restorative procedures. Method: Randomized clinical trial with two arms, double blind, interventional, prospective. The sample consisted of 20 male patients, with an average age of 20 years. Totaling 70 teeth to be treated. The teeth were divided into two groups: Group R (Control Group, n = 35), treated with a standard restorative procedure. Group D (Study group n = 35), treated using CEMENT PBS CIMMO DTA®, as an indirect capper of the pulp wall. The evaluation was carried out by a masked examiner for both groups. Sensitivity tests were performed before the restorative procedure, at 48 hours, 7, 15 and 30 days after the procedure. The analysis included pain caused by thermal stimuli: Cold Test (TM); horizontal (TPH) and vertical (TPV) percussion; Bite Test (TM) and Pain Decline Time (DD) was measured. Measured using Visual Analog Scale (EVA).
详细描述
The present study is a clinical trial: an intervention model, prospective, randomized, double-blind (patients and evaluator). It was held at the Dental Office of the 14th Field Artillery Group - Pouso Alegre (MG), Military Organization of the Brazilian Army in conjunction with the University of Vale do Sapucaí (UNIVÁS), Pouso Alegre, Minas Gerais, Brazil; in the period from 23 March 2020 to 18 January 2021.
Participants were initially evaluated according to the inclusion and non-inclusion criteria of the research. Clinical examinations were performed initially using a mouth mirror, explorer probe (Golgran®, São Caetano do Sul, SP, Brazil). The data were recorded on clinical records for screening. The radiographic examination included performing periapical radiographs as diagnostic aids, for participants who met the inclusion criteria during the clinical examination. Oral hygiene guidelines were provided to all research participants. To begin the service, an anamnesis form was filled out.
Randomization occurred after applying the inclusion and non-inclusion criteria of the patients, 20 were selected, according to the initial clinical examination.
The 20 patients were randomized and the random sequence for submission to radiographic examinations was determined, defining 70 teeth to be treated, within the study criteria.
As for the group that each tooth would belong to; 70 brown envelopes were made: 35 containing green paper, belonging to the standard restorative procedure group and 35 containing pink paper, belonging to the DTA® group. Before starting the procedure for each tooth, the patient was asked to choose the envelope. Thus, the sequence of treatments was determined. The envelopes chosen for each treatment were discarded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The study has double blind masking: as for patients and professional evaluator of the results
入排标准
- 年龄范围
- 18 Years 至 20 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Minimum age of 18 years, with maximum age of 20 years.
- •Periapical radiography for diagnosis with detection of the presence of carious lesion in premolar or permanent molar dentin.
- •Lesion depth and cervical width of at least 1 mm, without pulp exposure.
- •Presence of the antagonist, which must be a natural tooth, the same for adjacent teeth.
- •Presence of vital pulp and absence of spontaneous painful symptoms.
- •Presence of teeth without prior restorative treatment and oral health.
排除标准
- •Patients who did not show up for post-operative evaluations.
- •Patients who gave up participating in the study, after being included, for personal reasons.
- •Patients tested positive for the SARS-Cov-2 virus, unable to be assessed for the required confinement.
- •Treated patients in which the teeth presented, in the postoperative evaluations, the presence of inflammation and necrosis.
结局指标
主要结局
Assessment of postoperative sensitivity in posterior teeth: before the procedure, 48 hours later, 7; 15 and 30 days later. Thermal test.
时间窗: Sensitivity tests (thermal tests) were performed before the restorative procedure, 48 hours, 7, 15 and 30 days after the procedures
Evaluate the postoperative sensitivity (thermal test) on posterior teeth, restored with CEMENT PBS CIMMO DTA®, as a lining material, and later restorations with composite resin.
次要结局
- Evaluation of postoperative sensitivity in posterior teeth. Sensitivity test. Before the procedure, 48 hours later, 7; 15 and 30 days later. Percussion test.(Sensitivity tests (percussion tests) were performed before the restorative procedure, 48 hours, 7, 15 and 30 days after the procedures)
研究者
José Dias da Silva Neto
Professor Doctor
Universidade do Vale do Sapucai