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临床试验/NCT07592455
NCT07592455已完成不适用

Correlation Between the Clinical Presentation of Pulp and the Biological Mediators in Gingival Crevicular Fluid and the Inflamed Pulpal Tissue

Ain Shams University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年9月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
biological markers level

研究概览

简要总结

The aim of the present study was to Correlate between the clinical presentation of pulp and the biological mediators in gingival crevicular fluid and the inflamed pulpal tissue.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy male and female individuals aged between 18 and 50 years
  • No physical or mental disabilities
  • No underlying systemic diseases
  • Mandibular permanent premolar teeth diagnosed with symptomatic irreversible pulpitis with apical periodontitis
  • Mandibular permanent premolar teeth diagnosed with symptomatic irreversible pulpitis without apical periodontitis
  • Diagnosis based on the terminology of the American Association of Endodontists (2009)
  • Patients who provided written informed consent
  • Fully developed teeth with no previous pulp exposure
  • Positive response to cold testing
  • Positive response to electric pulp testing

排除标准

  • Requirement for antibiotic prophylaxis
  • Diabetes or hematologic disorders
  • Use of anti-inflammatory drugs, antibiotics, or antidepressants within the previous four weeks
  • Pregnancy at the time of treatment
  • Heavy plaque or calculus accumulation
  • Gingival redness and bleeding
  • Severe gingivitis or generalized periodontitis
  • Gingival pocket depths greater than 3 mm
  • Negative response to sensibility testing (cold test or electric pulp testing)
  • Presence of apical radiolucency (PAI > 2)
  • Previously initiated endodontic treatment
  • Internal or external root resorption
  • History of trauma
  • Severe calcific metamorphosis with obliterated root canal spaces on periapical radiographs
  • Vertical root fractures
  • Mobility greater than Grade I (Miller's mobility index)
  • Swelling or sinus tract associated with the treated tooth
  • Presence of periodontal-endodontic lesions
  • Teeth that could not be properly isolated with a dental dam
  • Collection of less than 10 µL of blood from each site
  • Conflicting clinical and radiographic findings preventing clear group assignment
  • No bleeding from one or more canal orifices (possible partial necrosis)

研究组 & 干预措施

lower premolars

Experimental

root canal treatment and samples of biomarkers

干预措施: root canal treatment (Procedure)

lower premolars

Experimental

root canal treatment and samples of biomarkers

干预措施: samples from Gingival crevicular fluid (Diagnostic Test)

control teeth / contralateral tooth

Active Comparator

samples of biomarkers

干预措施: root canal treatment (Procedure)

control teeth / contralateral tooth

Active Comparator

samples of biomarkers

干预措施: samples from Gingival crevicular fluid (Diagnostic Test)

结局指标

主要结局

biological markers level

时间窗: 2 months

TNF-alpha and sub P

次要结局

  • Pain score through the Visual analogue scale(1 week)
  • clinical presentation of irreversible pulpitis(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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