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临床试验/NCT05145686
NCT05145686已完成1 期

The Role of Matrix Metalloproteinases on the Primary Teeth Pulpotomy Treatments With MTA and Biodentine

Ege University2 个研究点 分布在 2 个国家目标入组 57 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
57
试验地点
2
主要终点
Comparison of the clinical and radiographic success of MTA and Biodentine in primary teeth pulpotomy treatment

研究概览

简要总结

Matrix metalloproteinases (MMPs) are important zinc enzyme group that responsible for reducing extracellular matrix components. It has been reported that MMPs play an important role in pulpal inflammation. The aims of this in vivo study was to compare the expression levels of MMP-2, -8 and -9 in primary molars with reversible and irreversible pulpitis and to compare the clinically and radiographically success of MTA and Biodentine materials at the end of 18 months.

详细描述

A total of 63 mandibular primary second molar teeth of 57 healthy and cooperative children aged between 5-10 years were included in this study. The Ethical Committee of the Medical Faculty of Ege University approved the study (Reference No: 16-7/14). Detailed treatment plan was explained to the children and the parents and written informed consents were obtained.

Periapical radiographs were obtained pre-operatively. Patients with a tooth showing clinical or radiographic evidence of a deep carious lesion extending close or into the pulp chamber were considered for potential inclusion.

The teeth were assigned to different groups according to the clinical diagnosis. The diagnosis were based on strict clinical and radiographic criteria. When the dental pulp was exposed during caries removal, the following clinical and radiographic diagnostic criteria were applied; Group I (teeth with reversible pulpitis): Slight clinical symptoms of minor intensity, slightly exaggerated reaction to cold or sweet stimuli, no history of pain, no sensitivity to chewing or percussion, bleeding time from the exposed pulp tissue less than 5 minutes, and no widening of the periodontal ligament space. In pulpotomy group teeth with pulpal exposure smaller than a pinpoint, teeth with purulent/viscous, dark colored exudate detected at the exposure site, and necrotic teeth were excluded.

Group II (teeth with irreversible pulpitis): Spontanous pain, sensitivity to chewing or percussion, bleeding time from the exposed pulp tissue more than 5 minutes, and widening of the periodontal ligament space, periapical lesion.

For ethical reasons, there was no control group with blood samples from healthy caries-free teeth. All primary molars were distributed between the two treatment groups as pulpotomy (Group I, n=42) and pulpectomy (Group II, n=21).

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

observers were blinded

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Cooperative pediatric patients aged 5-10 years,
  • Deep carious lesion in mandibular primary second molars,
  • The subjects did not receive any antiinflammatory medication 3 months prior to the study,
  • Feasible restorative treatment,
  • Positive parental informed consent.

排除标准

  • Uncooperative children,
  • Children with medically compromised disease,
  • Presence of pathological root resorption and/or bone defect,
  • Physiological root resorption more than one-third of the root,
  • Unrestorable teeth,
  • Negative parental informed consent.

结局指标

主要结局

Comparison of the clinical and radiographic success of MTA and Biodentine in primary teeth pulpotomy treatment

时间窗: 18 months

MTA and Biodentine materials were used in primary molars with reversible pulpitis. At the end of 6, 12 and 18 months, all teeth were evaluated clinically and radiographically based on AAPD criteria: (1) absence of spontaneous pain and/or sensitivity to pressure; (2) absence of sinus, fistula, edema, and/or abnormal mobility; (3) absence of radiolucency at the interradicular and/or periapical regions; (4) absence of internal or external root resorption.

The role of MMP-2, 8 and 9 in reversible and irreversible pulpitis

时间窗: 18 months

The expression levels of MMP-2, 8 and 9 were detected

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilsah Cogulu

Prof. Dr.

Ege University

研究点 (2)

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