Effect of Low-Level Diode Laser on Dentin Topography And Sensitive Non-Carious Cervical Lesions Prior to Composite Restoration, And Dentin Bonding And Clinical Durability of Composite Restorations (A Two Year Split-mouth Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Dentin Hypersensitivity Assessed from Baseline to After Exposure to Diode Laser Radiation.
研究概览
简要总结
This study will investigate the efficacy of three diode laser wavelengths 445 nm, 660 nm, 970 nm when applied just before placement of composite restoration on reducing postoperative sensitivity from Non-carious cervical lesions (NCCLs) with class V cavity preparation.
详细描述
In this randomized clinical trial, patients with NCCLs will be included (four teeth in each participant). After class V cavity preparation in the NCCLs, the teeth will be randomly assigned into four groups according to diode laser irradiation wavelength Group 1 (placebo) laser simulation and Group 2 (445 nm) diode laser wavelength, Group 3 (660 nm) diode laser wavelength, and Group 4 (970 nm) diode laser wavelength. Following laser irradiation, the universal self-etch adhesive will be applied and all the cavities will be restored with the same resin composite. Tooth sensitivity to a cold stimulus will be recorded using a visual analogue scale (VAS) before treatment and on follow-up days 1, 14 followed by 1, 3, and 6 month after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The allocation will be hidden from patients, and they will not know which teeth are lased and which will receive the placebo treatment. In addition, for blinding, the restoration procedure is performed by one person, and the cold test is performed by another person who is unaware of the distribution. Furthermore, the statistician will be blinded.
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •NCCLs on the Buccal Surface of Teeth, Maxilla, or Mandible.
- •Preoperative VAS Score >
- •Good Oral Hygiene. Score (0-1.2).
- •Teeth Must be Vital.
排除标准
- •Teeth with a History of Trauma, Dental caries, Defective Restoration, Pulpitis, Occlusal Restoration.
- •Teeth with Periodontal Disease or History of Surgical Procedure.
- •Use of Desensitizing Toothpaste or Solutions in the Past 3 Month.
- •Patients Taking Analgesics within 72 h Before Sensitivity Testing.
- •Patients with Known Allergic Reactions Against Any Material to be Used.
- •Patients with a History of Psychological Diseases and those Taking Antipsychotic Medications.
- •Pregnancy or Nursing.
- •Unwillingness of the Patient to the Treatment Procedure.
结局指标
主要结局
Change in Dentin Hypersensitivity Assessed from Baseline to After Exposure to Diode Laser Radiation.
时间窗: Change in Pain Scores From Baseline on the Visual Analog Scale at Day 1, Day 14, Followed by 1,3, and 6 Month Postoperatively.
Dentin Hypersensitivity is Determined using Cold Stimulus. Utilizing Visual Analog Scale (VAS) Reading 0-10 Where 0 is No Pain, While 10 is the Most Experienced Pain.
次要结局
- Clinical assessment for esthetic, functional, and biological responses to restorative materials.(Time frame: Restorations are evaluated for esthetic, functional, and biological properties over follow-up periods of 6 months, 12 months, and 24 months.)
研究者
Raghda Hegazy
Principal Investigator
Alexandria University