Efficacy Of Proinflammatory Cytokines in the Clinical And Radiographic Outcomes of Different Primary Molar Pulpotomy Agents: A Comparative Study Featuring A Novel Biomarker For Pulpal Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Presepsin amount measurement using ELISA kit
研究概览
简要总结
One of the main goals of pediatric dentistry is to preserve the functions and structures of primary teeth until the time of exfoliation. Especially carious lesions are the main factor in the early loss of primary teeth. Today, primary teeth can be kept in the mouth by applying different treatments depending on the degree of inflammation caused by carious lesions in the pulp tissue.Coronal pulpotomy application in asymptomatic primary teeth with deep carious lesions near the pulp is one of the most common methods to achieve the goal of retaining the tooth in place. The purpose of the pulpotomy technique is to remove the affected pulp tissue and maintain the normal function of the unaffected root pulp tissue until the tooth is naturally ready to exfoliate.
Studies have shown that the degree of pulp inflammation and the materials used are effective in the success of this treatment. In studies evaluating pulpal inflammation, many biomarkers have been shown to play significant roles at different levels of inflammation. Recently, Presepsin has been studied as a biomarker for detecting bacterial infections. However, there is no study in the literature on the use of Presepsin as a biomarker in endodontic treatments. In our study, it is thought that Presepsin biomarker could be detected in cases of acute or chronic infection in pulp tissue and could be considered as one of the mediators of pulpal inflammation.
Based on this, the aim of our study is to investigate whether the materials used in covering the pulp or the level of inflammation in the remaining pulp tissue is more important for the success of pulpotomy treatment. The inflammation level in the remaining pulp tissue will be measured using IL-6, IL-8, and Presepsin. Then, the one-year success of treatment in different groups where pulp tissue is randomly covered with MTA, NeoMTA, Biodentine, and Zinc oxide eugenol will be demonstrated. Thus, it will be evaluated whether materials previously found to be quite successful in other studies achieve success in pulps with high inflammation levels.
详细描述
Tooth decay is a commonly encountered chronic infectious disease in children. Coronary pulpotomy treatment is generally preferred for teeth with deep decay lesions that are clinically and radiographically asymptomatic. The success of this treatment method is highly dependent on the inflammatory status of the pulp and the materials used. In predicting the clinical success of pulpotomy treatment, the severity of pulp inflammation must also be evaluated. A molecular approach that aids in the clinical distinction between reversible and irreversible pulpitis can increase the success rate of vital pulp therapy by accurately assessing the inflammation status of the pulp. Although various mediators' increases in advanced pulpal inflammation have been examined in many previous studies, the role of many biomolecules involved in pulpal inflammation has not yet been determined. Due to the complex nature of inflammatory pulp disease, it is unlikely that a small number of mediators would provide sufficient information to diagnose advanced inflammatory disease. Therefore, studies aimed at identifying new mediators remain relevant in dentistry. Presepsin, discovered in 2004, is a biomarker with high sensitivity and specificity that is highly important in the early diagnosis of bacterial diseases in medicine. When dental literature is reviewed, it is observed that presepsin has not been evaluated for the detection of bacterial inflammation in the pulp, and it is believed that this biomarker could be used for the early detection of pulpal inflammation. Thus, with the ability to measure presepsin levels using patient kits, pulpal inflammation can be quantitatively evaluated, aiding in the provision of accurate pulp treatments.The aim of our research is to investigate whether presepsin, a new biomarker that can be rapidly detected in bacterial infections, can also be used as a mediator in the detection of pulpal infections, and to evaluate the levels of the reliable markers of pulpal inflammation, IL-8 and IL-6, comparing the effect of these mediators on the success of treatment with the most successful materials used in pulpotomy treatment, MTA, Neo MTA, Biodentine and Zinc oxide eugenol.
This study was conducted in accordance with the Ataturk University Faculty of Medicine Ethics Committee approval (Date: 05.2021/ Session no:04/ Decision no:66) and guidelines of the Helsinki Declaration. Also the parents of child patients were comprehensively briefed about the procedures before the treatment and their written consents were obtained. Initially, a total of 75 children aged 4-9 years old (36 girls and 39 boys) with no systemic disease and presenting at least one primary second molar indicated for pulpotomy were included in the study and 4 pulpotomy agents (MTA, Biodentine™, NeoMTA™ and ZOE) were randomly divided into four study groups of 30 teeth and pulpotomy was applied to a total of 120 teeth.
In order to randomly distribute the study groups, Research Randomizer (Version 4.0) computer software from http://www.randomizer.org/ was used to generate a list before starting pulpotomy and pulpotomy agents were used accordingly.
Protocols for Treatment and Sample Storage:
For a better visibility a rubber-dam is placed over the tooth requiring pulpotomy following local anesthesia. Endodontic cavity was accessed by first removing the carious tissue, unroofing the pulp chamber with diamond round bur (no:18), removing the coronal tissue using a sterile tungsten carbide round bur (no:14) mounted low-speed contra-angled handpiece and clearing the remaining pulpal tissue with an excavator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children between the ages of 6-9
- •Children who do not have any systemic disease
- •Primary second premolars in which physiological root resorption has not started.
- •Cases where tooth decay at the interfaces exceeds ½ of the dentin thickness.
- •Primary second premolars with provoked pain
- •Lack of percussion sensitivity
- •Absence of radiolucent image in the periapical and furcal areas on x-ray
- •Clinical absence of abscess and fistula
排除标准
- •Children with systemic diseases
- •Having percussion sensitivity
- •Radiolucent appearance in the periapical and furcal areas on x-ray
- •Clinical presence of fistula
- •Having night pain
结局指标
主要结局
Presepsin amount measurement using ELISA kit
时间窗: 6 Month - 1 Year
Presepsin levels were measured in ng/ml using the ELISA method. The measurement procedure was followed according to the manufacturer's instructions. The anti-Presepsin polyclonal antibody was pre-coated on 96-well plates. Blood samples and a biotin-conjugated antibody were added to the wells supplemented with Avidin-Biotin-Peroxidase Complex and 3,3',5,5'-tetramethylbenzidine in a mildly acidic buffer. A blue-colored product was produced and turned to yellow after an acidic stop solution was added. The intensity of the color yellow was proportional to the Presepsin amount bound on the plate. The optical density absorbance was measured spectrophotometrically at 450nm in a microplate reader and the concentration of Presepsin was calculated. For the expression of Presepsin concentrations in the samples, a standard curve was used.Optimal threshold values (cut-offs) for biomarkers were determined based on sensitivity and specificity, which were calculated from a ROC curve.
Clinical Success After Pulpotomy Treatment
时间窗: 6 Month - 1 Year
No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth.
IL-6 amount measurement using ELISA kit
时间窗: 6 Month - 1 Year
IL-6 levels were measured in ng/ml using the ELISA method. The measurement procedure was followed according to the manufacturer's instructions. The anti-IL-6 polyclonal antibody was pre-coated on 96-well plates. Blood samples and a biotin-conjugated antibody were added to the wells supplemented with Avidin-Biotin-Peroxidase Complex and 3,3',5,5'-tetramethylbenzidine in a mildly acidic buffer. A blue-colored product was produced and turned to yellow after an acidic stop solution was added. The intensity of the color yellow was proportional to the IL-6 amount bound on the plate. The optical density absorbance was measured spectrophotometrically at 450nm in a microplate reader and the concentration of IL-6 was calculated. For the expression of IL-6 concentrations in the samples, a standard curve was used.Optimal threshold values (cut-offs) for biomarkers were determined based on sensitivity and specificity, which were calculated from a ROC curve.
Radiographic Success After Pulpotomy Treatment
时间窗: 6 Month - 1 Year
No signs of root resorption (internal or external), no signs of furcation involvement or periapical radiolucency, no signs of loss of lamina dura, presence of normal appearance of periodontal ligament space.
IL-8 amount measurement using ELISA kit
时间窗: 6 Month - 1 Year
IL-8 levels were measured in ng/ml using the ELISA method. The measurement procedure was followed according to the manufacturer's instructions. The anti-IL-8 polyclonal antibody was pre-coated on 96-well plates. Blood samples and a biotin-conjugated antibody were added to the wells supplemented with Avidin-Biotin-Peroxidase Complex and 3,3',5,5'-tetramethylbenzidine in a mildly acidic buffer. A blue-colored product was produced and turned to yellow after an acidic stop solution was added. The intensity of the color yellow was proportional to the IL-8 amount bound on the plate. The optical density absorbance was measured spectrophotometrically at 450nm in a microplate reader and the concentration of IL-8 was calculated. For the expression of IL-8 concentrations in the samples, a standard curve was used.Optimal threshold values (cut-offs) for biomarkers were determined based on sensitivity and specificity, which were calculated from a ROC curve.
次要结局
- The Correlation Between Pulp Bleeding Time During Treatment and Radiographic Success After Pulpotomy Treatment(1 Year)
- The Correlation Between Pre-Treatment Pain Presence and Radiographic Success After Pulpotomy Treatment(1 Year)
- The Correlation Between The Severity of Pulp Bleeding During Treatment and Radiographic Success After Pulpotomy Treatment(1 Year)
研究者
AYBİKE BAŞ
assisstant proffessor- pediatric dentistry
Ataturk University