Longitudinal Results of a 10-years Clinical Trial of Sealed Margin Failures of Amalgam Restorations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changes of Amalgam restorations quality according to United Stated Public Health Service (USPHS)
研究概览
简要总结
- Assess the effectiveness of sealing localized marginal defects of amalgam restorations that were initially scheduled for replacement of restorations.
- The hypothesis was that sealed defective margins of the amalgam restorations shows similar performance than replacement amalgam restorations.
详细描述
Study Design
Were examined 157 patients with 586 amalgam restorations that were recruited at the Operative Dentistry Clinic, at the Dental School, University of Chile with the indication of amalgam replacements, of them, a cohort of thirty two patients (19 females and 13 males, mean age = 27 years old), with 73 Class I amalgam restorations, that presented one or more localized margin defects (Bravo or Charlie according to modified United State Public Health Service, USPHS criteria), were included in the study. The protocol was approved by the Institutional Research Ethics Committee of the Dental School at the University of Chile, Investigation Project, School of Dentistry (0205) and all patients signed the informed consent form and completed the registration form. Only Faculty members were accepted to provide the treatment.
Treatment Groups Criteria: 73 restorations with defective margins were evaluated in accordance with the modified USPHS criteria and assigned to either the sealant (n=26), repair (n=21) and control groups (n=26).
Restorations Assessment: The quality of the restorations were evaluated using the modified U.S. Public Health System/Ryge criteria. Two examiners assessed the restorations independently and by visual and tactile (mouth mirror number 5) examination using an explorer (N° 23) and indirectly by radiographic, examination, for interproximal observation (Bite Wing). All the restorations were examined at baseline and each year during four and ten years after treatment. The restorations assessment was carried out by five parameters: marginal adaptation (MA), roughness (R), secondary caries (SC), marginal stain (MS) and teeth sensitivity (TS). If any difference was recorded between the 2 independent examiners, and they did not reach an agreement, a third clinician was called to assist with the process decision. If the three clinicians they did not reach an agreement, the lower score was recorded. All three clinicians participated in calibration exercises at the beginning and before the last examination took place and the inter-examiner reliability results were Kappa=0.74 at the baseline and Kappa=0.87 at the ten year.
A change from Bravo to Alpha was considered an improvement and a change from Alpha to Bravo was considered downgrade.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Patients with contraindications for regular dental treatment based on their medical history
- •Special aesthetic requirements that could not be solved by this alternative treatment
- •Xerostomia or who were taking medication that significantly decreased salivary flow
- •High caries risk
- •Psychiatric or physical diseases, that interfered with teeth hygiene.
结局指标
主要结局
Changes of Amalgam restorations quality according to United Stated Public Health Service (USPHS)
时间窗: Baseline and 10 after treatment
Restorations Assessment: The quality of the restorations were evaluated using the modified U.S. Public Health System criteria. Two examiners assessed the restorations independently and by visual and tactile examination. All the restorations were examined at baseline and ten years after treatment. The restorations assessment was carried out by five parameters: marginal adaptation, roughness, secondary caries, marginal stain and teeth sensitivity. All three clinicians participated in calibration exercises at the beginning and before the last examination took place and the inter-examiner reliability results were Kappa=0.74 at the baseline and Kappa=0.87 at the ten year.
次要结局
未报告次要终点
研究者
Gustavo Moncada
Main Investigator
University of Chile