Comparison of the Effectiveness of Grape Seed Extract (GSE) and Low-level Laser Therapy in the Management of Dentin Hypersensitivity: A Randomized Control Trial
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
- The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
研究概览
简要总结
Dentin hypersensitivity (DH) is a common clinical problem frequently seen in dental patients. According to Splieth et al., the prevalence of dentin hypersensitivity is 3-98% in adult population.DH is described as a short, sharp pain or discomfort that responses to certain stimuli, typically thermal, tactile, osmotic or chemical, due to exposed dentinal surface which can be explained by the hydrodynamic theory.
The laser is a narrow, focused beam of light emitted to vaporise, fuse, melt, or seal dentinal tubules using laser heat to induce hydroxyapatite crystals for recrystallisation of the mineral component of dentine. The obliteration of dentinal tubules is caused by heat generated by laser beam which inhibits the transmission of the stimulus in the dentinal tubules.
Grape seed extract contains proanthocyanidins (PA) which is able to bind to proline-rich proteins, like collagen, and contributes in enzyme proline hydroxylase activity that is essential for the biosynthesis of collagen in the dentin. The cross-linking action of collagen fibrils in dentin also able to prevent mineral loss.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with at least three sensitive tooth by gingival recession or tooth wear >2 scores on the VAS scale.
- •Tooth wear index score <3 (Smith and Knight tooth wear index)
- •Systemically healthy patient.
- •20-50 years of age.
排除标准
- •Teeth with caries, cracked teeth, mobile teeth and pulpitis.
- •Deep periodontal pockets (probing depth >6 mm), periodontal surgery within the previous 3 months.
- •Recent desensitizing therapy
- •systemic diseases and gastric diseases (GERD)
- •Allergy to active ingredients.
研究组 & 干预措施
Grape seed extract
grape seed extract with 95% proanthocyanins will be applied topically to the hypersensitive dentin area for 10 minutes, followed by rinsing with water.
干预措施: Grape Seed Extract (Drug)
Low-level laser therapy
The low-level laser diode treatment of 810 nm will be performed using a commercially available diode laser device. The device will be set at a wavelength of 810 nm, with a power output of 0.5 watts tip of diameter 300 μ in non-contact mode starting at a distance of 5-6 mm away from the hypersensitive tooth area and slowly approaching within a distance of 2-3mm in a scanning motion covering the entire hypersensitive tooth area for a period of 30 seconds to 1 minute.
干预措施: Low-level laser therapy (Device)
Combination of low-level laser therapy and grape seed extract
Grape seed extract will be applied topically to the hypersensitive dentin area for 10 minutes, followed by low-level laser diode treatment.
干预措施: Grape Seed Extract (Drug)
Combination of low-level laser therapy and grape seed extract
Grape seed extract will be applied topically to the hypersensitive dentin area for 10 minutes, followed by low-level laser diode treatment.
干预措施: Low-level laser therapy (Device)
结局指标
主要结局
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
时间窗: 7th day
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)(0 to 10) after treatment.
次要结局
未报告次要终点
研究者
Dr. Anchu Rachel Thomas
Associate Professor Dr.
Manipal University College Malaysia