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临床试验/NCT06418958
NCT06418958招募中不适用

In Vivo Temperature Changes Caused by Exposure to Short- and Long-wavelengths

University of Florida1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Temperature Change

研究概览

简要总结

Red light has been shown to be less harmful than blue light in vitro and in vivo. Although red light has been already introduced in the market and is currently being used in patients for several reasons, no data exist on the use of red light applied to restorative procedures. This study aims to specifically measure the in vivo temperature rise in simulated restorative procedures using blue light (standard) and red light and its post-operative sensitivity rates.

详细描述

Light-cured materials revolutionized dentistry as they allowed to control the setting of the materials in a timely manner simply upon light exposure. Although blue light has been routinely used to cure dental restorative materials for over 50 years, there are still potential risks to dental patients. These risks include gingiva burn or recession and pulp inflammation that can lead to necrosis in more severe situations due to the heat generated by this short wavelength (blue light). In addition, blue light has direct deleterious effects on cells, including irreversible imbalance in reactive oxygen species (ROS), damage to the mitochondrial DNA, and promoting collagen degradation. On the other hand, long wavelengths (such as red light) are known to have opposite effects, reducing inflammation and increasing cell proliferation. Although red light has been already introduced in the market and is currently being used in patients for several reasons, no in vivo data exist on the use of red-light applied to restorative procedures. Thus, this study aims to specifically measure the in vivo temperature rise in the tooth and gingival tissues surrounding restorative procedures using blue light (standard of care) and red light (investigational device) and evaluate/compare its post-operative sensitivity rates. The research hypothesis is that red light will generate less heat and less post-operative sensitivity than blue light (standard of care) while being used in dental restorative procedures.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •ASA I classification
  • •Fully erupted pre-molar(s);
  • •Absence of caries;
  • •Absence of restoration.

排除标准

  • •Radiographic constriction of the pulp chamber;
  • •Absence of apical closure;
  • •Formation of pulp stones or diffuse calcification at the pulp chamber;
  • •Presence of active carious lesions;
  • •Diagnosed reversible or irreversible pulpitis;
  • •Existing periapical lesion;
  • •Existing or planned root canal treatment.

研究组 & 干预措施

Blue Light

Active Comparator

Light-curing procedure performed using blue light emission.

干预措施: Blue Light (Device)

Red Light

Experimental

Light-curing procedure performed using red light emission.

干预措施: Red Light (Device)

结局指标

主要结局

Temperature Change

时间窗: During restorative procedure.

Temperature changes in degrees Celsius will be live-recorded by means of temperature probes for surface temperature acquisition.

次要结局

  • Post-Operative Sensitivity(One week (±2 days) after intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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