Antimicrobial Photodynamic Therapy as an Adjunct for Management of Deep Caries Lesions - Study Protocol for a Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 160
- 主要终点
- Changes in Microbiological Evaluation
研究概览
简要总结
Alternatively to conventional treatments, chemo-mechanical caries removal agents can be used. A modality of treatment that has been increasing in dentistry is antimicrobial photodynamic therapy (aPDT). Bixa orellana, is being researched for application in aPDT. This protocol aims to determine the effectiveness of aPDT with Bixa orellana extract in deep caries lesions. Methods and analysis: A total of 160 teeth with deep occlusal dental caries will be selected and divided in 3 groups: G1 - control group (Caries removal with a lowspeed drill); G2 - Partial Caries Removal with Papacarie; G3 - Partial Caries Removal with Papacarie and application Bixa orellana extract (20%); G4 - Partial Caries Removal with Papacarie and application Bixa orellana extract (20%) with LED (aPDT). After treatment, all the teeth will be restored with glass ionomer cement and followed up clinically and radiographically, with evaluations at immediately, 1 week, 1, 3, 6, and 12 months. Dentin samples before and after treatment will be analyzed microbiologically. The data will be submitted to descriptive statistical analysis of the association between the categorical variables using the chi-square test and Fisher exact text. The Student t test and analysis of variance will be used for the comparison of mean signs and symptoms of reversible pulpitis. Pearson correlation coefficients will be calculated for the analysis of correlations among the continuous variables.
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
The clinical evaluations of the carious tissue removal, as well as the microbiological and radiographic analyses, will be performed by examiners blinded to the treatments performed on each tooth.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adequate health with no systemic conditions;
- •Adequate cooperation;
- •Clinically presenting at least 1 permanent molar with an acute, active caries on the dentin not surpassing 2/3 and only involving the occlusal face, with direct view and access as well as no clinical or radiographic signs of pulp involvement.
排除标准
- •Systemic adverse health condition;
- •Uncooperative behavior;
- •Class II, III, IV, or V carious lesion based on Black classification;
- •Clinically: caries involving enamel, deficient restorations, small carious lesions on dentin with no access for manual scalers, hidden caries, sign or symptom of pulp involvement, clinical impossibility of restoration;
- •Radiographically: evidence of pulp involvement, carious lesion extending beyond 2/3 of dentin.
结局指标
主要结局
Changes in Microbiological Evaluation
时间窗: Baseline and immediately after treatment.
A sample of caries-affected dentin will be taken from each selected tooth before the removal of the carious tissue. All procedures will be performed in duplicate, and the mean of the counts will be calculated. The results will be expressed in CFU of SM and LB as well as in proportion of streptococcus (% S/VM), SM group (% SM/VM and lactobacilli (% LB/VM) in relation to the total of VM. Immediately after the removal of the carious tissue, samples of the remaining dentin will be taken with a Meyhoefer auricular n° 2 curette and the procedures will be repeated.
次要结局
- Evaluation of time required for procedure(During the procedure.)
- Changes in Radiographic evaluation(Baseline, immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.)
- Evaluation of need for local anesthesia during intervention(During the procedure.)
- Degree of pain/discomfort of children during procedure(During the procedure.)
- Changes in Clinical Evaluation(Immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho