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临床试验/NCT06685016
NCT06685016招募中不适用

Evaluation of Dental and Periodontal Health After Interproximal Enamel Reduction, in Patients in Orthodontic Treatment With Clear Aligners, and Comparison Between Laser Diode and Sodium Fluoride for the Treatment of Dentin Hypersensitivity

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月24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
30
试验地点
1
主要终点
Assestment of DH after IPR

研究概览

简要总结

This study aimed to evaluate dental and periodontal health after interproximal enamel reduction and to compare Laser diode (a device used in the Orthodontic Program) and sodium fluoride (often used in the Orthodontic Program and in the Material Dental Program). The hypothesis was that the intervention groups would show a lower dentin hypersensitivity incidence than the control group during orthodontic treatment.

详细描述

Interproximal enamel reduction (IPR) is a common procedure used during orthodontic treatment aimed to reduce mesio-distal tooth size dimensions to address lack of space (mild and moderate crowding), Bolton tooth-size discrepancy, correction of morphologic anomalies, tooth reshaping and management of gingival papilla. It is a practice that also offers an attractive alternative to overcome difficulty when extracting premolars and resolve the instability of overexpansion in non- extraction cases, improving the stability of the arches.

IPR may be exploited inconjunction with fixed appliance treatment, although its application with removable appliance treatment such as clear aligners is commonplace.

Clinically, the most accepted IPR techniques include air-rotor stripping with fine tungsten-carbide or diamond burs, handpiece or contra-angle-mounted diamond-coated disks, and handheld or motor- driven abrasive metal strips.

Some of these techniques can cause deep furrows and scratches that cannot be removed by polishing . In addition, these surface irregularities could promote the adherence of plaque bacteria and induce iatrogenic damage, such as dental caries, gingival inflammation, periodontal tissue breakdown, gingival recession and increased sensitivity of the shaped teeth to hot and cold temperatures.

Sometimes, after IPR, it is possible to have dentin hypersensitivity (DH), attributed to exposure to dentinal tubules. This clinical condition is influenced by various factors, including patient' s age, the severity of crowding, pathological tooth wear, hypersensitivity before treatment and the amount of the removed enamel.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
17 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •to be in orthodontic treatment with clear aligners and this treatment requires interproximal enamel reduction;
  • •permanent dentition;
  • •good oral and periodontal health.

排除标准

  • •enamel defects;
  • •cervical caries;
  • •periodontal disease;
  • •history of trauma or craniofacial anomalies;
  • •pregnancy.

研究组 & 干预措施

Control Group

Experimental

Subjects will not receive any treatment

干预措施: Evaluation of Dentin hypersensitivity with VAS scale (Diagnostic Test)

Laser Diode Group

Experimental

Subjects treated with Laser Diode

干预措施: Evaluation of Dentin hypersensitivity with VAS scale (Diagnostic Test)

Sodium Fluoride Group

Experimental

Subjects with a sodium fluoride gel treatment.

干预措施: Evaluation of Dentin hypersensitivity with VAS scale (Diagnostic Test)

结局指标

主要结局

Assestment of DH after IPR

时间窗: from 3 to 4 months

Dentin hypersensitivity will be assessed before and after interproximal enamel reduction and after the application of therapeutic protocols. Dentin hypersensitivity will be performed with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli.

Reduction of the Dentin Hypersensitivity

时间窗: from 3 to 4 months

. Dentin hypersensitivity will be performed with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli.

次要结局

  • Evaluation of Dentin hypersensitivity after the application of therapeutic protocols.(from 3 to 4 months)

研究者

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

Vincenzo Grassia

Associate Professor

University of Campania "Luigi Vanvitelli"

研究点 (1)

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