Comparative Efficacy of Erbium and Diode Laser Systems Alone or Combined With Fluoride-Based Desensitizing Agent in the Management of Dentinal Hypersensitivity: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Dentinal Hypersensitivity Assessment
研究概览
简要总结
This randomized controlled clinical trial aims to compare the effectiveness of Erbium laser (2940 nm), Diode laser (650 nm), combination Diode laser with fluoride varnish, and fluoride varnish alone in treating dentinal hypersensitivity. The study will recruit 96 adults aged 18-45 years with tooth sensitivity scores ≥4 on a 0-10 Visual Analogue Scale, randomly allocating 24 participants to each of four treatment groups. The primary outcome is reduction in tooth sensitivity measured at baseline, 1 week, 4 weeks, and 6 months post-treatment, with patient satisfaction as a secondary outcome. Conducted at Cairo University's Faculty of Dentistry, this 6-month follow-up study addresses the limitation of current treatments that provide only temporary relief, seeking to establish evidence-based protocols for optimal long-term management of dentinal hypersensitivity by evaluating whether laser therapies alone or in combination with fluoride offer superior and more durable pain relief compared to standard fluoride treatment alone.
详细描述
This randomized controlled clinical trial investigates the comparative efficacy of different laser systems and fluoride-based treatments for managing dentinal hypersensitivity, a prevalent clinical condition characterized by sharp, transient pain from exposed dentin in response to thermal, evaporative, tactile, or chemical stimuli. The study will recruit 96 participants aged 18-45 years with dentinal hypersensitivity scores ≥4 on a Visual Analogue Scale (VAS), randomly allocating them into four equal groups (n=24 each): Group 1 receiving Erbium:YAG laser treatment (2940 nm, 80mJ, 2Hz) which works through thermal tubule occlusion; Group 2 receiving Diode laser photobiomodulation therapy (650 nm, 100mW, 2J total dose) targeting neural modulation; Group 3 receiving combination therapy of Diode laser with 5% sodium fluoride varnish to exploit synergistic mechanisms; and Group 4 receiving fluoride varnish alone as the control comparator. The primary outcome measures dentinal hypersensitivity reduction using VAS scores (0-10 scale) assessed through standardized evaporative stimulus tests at baseline, 1 week, 4 weeks, and 6 months post-treatment, while secondary outcomes include patient satisfaction and treatment tolerability. Conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, with blinded outcome assessors and standardized protocols, this superiority trial addresses the clinical need for evidence-based, long-term effective treatments for dentinal hypersensitivity by comparing individual laser modalities against combination therapy and established fluoride treatments, potentially establishing optimal therapeutic protocols that provide both immediate relief and sustained tubule occlusion or neural modulation for improved patient quality of life.
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
- Single (Outcomes Assessor)
盲法说明
This randomized controlled trial uses a single-blind, parallel-group design to compare four treatments for dentinal hypersensitivity in 96 participants. Using computer-generated randomization and sealed envelope allocation, participants are equally divided into four groups receiving Erbium laser, Diode laser, combination Diode laser with fluoride, or fluoride alone. The study employs single-blind masking where outcome assessors and statisticians remain blinded to treatment assignments, while sham procedures (simulated laser/fluoride applications) minimize bias where complete blinding is impossible. Participants are followed for 6 months with Visual Analogue Scale measurements at baseline, 1 week, 4 weeks, and 6 months to assess treatment effectiveness using standardized protocols and pre-calibrated examiners.
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erbium Laser
Erbium:YAG laser (2940 nm) treatment alone using thermal ablation to seal dentinal tubules and reduce hypersensitivity.
干预措施: Fluoride varnish (Drug)
Diode Laser
Diode laser (650 nm) photobiomodulation therapy alone targeting neural modulation to reduce pain transmission.
干预措施: Fluoride varnish (Drug)
Combination Therapy
Diode laser (650 nm) followed immediately by fluoride varnish application combining neural modulation with tubule occlusion.
干预措施: Fluoride varnish (Drug)
结局指标
主要结局
Dentinal Hypersensitivity Assessment
时间窗: at baseline, 1 week, 4 weeks, and 6 months post-treatment
Dentinal Hypersensitivity Assessment Using Visual Analogue Scale
次要结局
- Patient Satisfaction(at baseline, 1 week, 4 weeks, and 6 months post-treatment)
研究者
Ayman Mohamed Elamin Taha
Assistant Lecturer
Cairo University
