Efficacy of Laser Doppler Flowmetry, as a Diagnostic Tool in Assessing Revascularization of Traumatised Teeth
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Changes in pulpal blood flow
研究概览
简要总结
The aim of the study is to evaluate the efficacy of Laser Doppler flowmetry in determining the changes in the pulpal blood flow during the post-traumatic period of traumatised permanent teeth.
详细描述
Traumatic injuries of permanent teeth in children and adolescents are very common. The conventional pulp vitality tests are inaccurate and unreliable techniques in assessing the pulp vitality during the post-traumatic period, as well as during the immature teeth examination. The aim is to evaluate the efficacy of Laser Doppler flowmetry in determining the changes in the pulpal blood flow during the post-traumatic period of traumatised permanent teeth. The study is designed as a randomized, split-mouth, controlled clinical trial. The measurement of the blood flow of the dental pulp of both, traumatised and non-traumatised teeth, will be performed, using a laser doppler flow monitor, emission wavelength 785nm±10nm, dual-channel laser Doppler monitoring option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fit and healthy subjects aged < 18-year-old;
- •Subjects with maxillary permanent incisor subjected to a traumatic injury without any dentoalveolar trauma involvement and have a contralateral homologous tooth with no signs/symptoms of injury;
- •Subjects attended their first dental visit within 3 days of the dental trauma;
- •Sensitivity value of the electric pulp test over 200 μA;
- •Subjects with at least one vital and non-traumatised maxillary incisor acting as a control tooth;
- •Ability to obtain a verbal acceptance from all the subjects to comply with all the treatments and follow-up timepoints attendance;
- •Ability to obtain written informed consent by the patients' parents/guardians for treatment, participation in the study and publication
排除标准
- •Subjects who were undergoing therapy for neurological conditions or with mental or cognitive problems;
- •Subjects who were taking sedative, analgesic, and/or anti-inflammatory medication 7 days prior to the treatment commencement;
- •Subjects who have never had any first dental visit or treatment;
- •Subjects with systemic diseases or physiological development delay;
- •Subjects with active infectious diseases such as; influenza, scarlet fever, etc.
- •Subjects with restorations covered more than half the labial surface of the investigated teeth.
结局指标
主要结局
Changes in pulpal blood flow
时间窗: 180 seconds
The traumatised and non-traumatised teeth, test and control, will be assessed by LDF, providing an accurate and precise investigation. The temperature in the dental office will be constant and the patient will be seated in a "state position" in the dental chair. According to the manufacturer's recommendations, a patient's relaxation of 10 minutes before the monitoring process will be obtained. The measurements of blood flow will be performed for 180 seconds at each session. All the measurements will be recorded.
次要结局
未报告次要终点