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临床试验/TCTR20240723002
TCTR20240723002尚未招募2 期

Clinical outcomes of bioactive restorative materials in class Il restored primary molar: Randomized clinical trial

n/a0 个研究点目标入组 65 人开始时间: 2024年7月23日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
65

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
4 Years 至 8 Years(—)
性别
All

入选标准

  • Age range: Participants are between 4 and 8 years old.
  • Health Status: Children with an American Society of Anesthesiologists (ASA) score of I, indicating good health.
  • Behavioral Assessment: A minimum rating of 3 on the Frankl scale, suggesting the child is likely to be cooperative.
  • Dental Condition: Presence of two proximal caries in primary molars involved dentin with similar size and shape in contralateral teeth without signs of pulp necrosis, with proximal and occlusal contact. If the patient has cavity at adjacent proximal contact, the cavity must be restored with composite resin prior to the experiment, randomized by computed random number generator (0,1)
  • Caries Evaluation: Class II cavities with an International Caries Detection and Assessment System (ICDAS) score 4-5, indicating visible dentin in a distinct cavity. With RA2 - RB4 ICCMS radiographic evaluation
  • Radiographic Criteria: The study includes teeth expected to naturally exfoliate in no less than two years, with radiolucency extending from proximal area to middle 1/3 of dentin or distinct loss of enamel surface from inner half of enamel to outer 1/3 of dentin (RA2 - RB4 ICCMS radiographic evaluation)
  • Absence of Pain and Infection: No spontaneous pain, no signs of infection such as fistulae, abscesses, swelling, or pain upon percussion.
  • Caries Risk: Participants identified as having a high to extremely high risk of caries.

排除标准

  • Systemic Health Conditions: Participants with systemic pathologies that could affect overall patient health are excluded.
  • Dental Anomalies: Any cases of teeth with developmental irregularities, including discoloration, atypical anatomy or shape, and excessive mobility, are not included.
  • Pulp Exposure: Teeth showing dental pulp exposure that necessitates either extraction or root canal treatment are also excluded from the study.
  • Dental Condition: Cavity extending above line angle after preparation or cavity at mesial of first primary molar (D)

研究者

发起方
n/a

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