Chemical and Laser Desensitization Approaches for Managing Dentin Hypersensitivity After Non-Surgical Periodontal Therapy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Decrease in hypersensitivity rate
研究概览
简要总结
A total of 62 patients diagnosed with Stage III-IV periodontitis underwent non-surgical periodontal therapy. At 24 hours post-treatment, patients were recalled to the clinic for reassessment using air-stimulated Visual Analog Scale (VAS) and Schiff Cold Air Sensitivity Scale measurements. Two teeth per patient were randomly selected based on a VAS score greater than 4 and a Schiff score of 2 or 3. A total of 52 patients who met the inclusion criteria were included in the study. This study was designed as a randomized, parallel clinical trial. The 52 patients were randomly allocated into three treatment groups: Group 1 received the desensitizing agent Gluma, Group 2 underwent Er,Cr:YSGG laser treatment, and Group 3 received a combination of Gluma and Er,Cr:YSGG laser therapy. Desensitizing agent applications were performed according to the designated treatment protocols.To assess changes in dentin hypersensitivity over time, patients were recalled for follow-up evaluations at 1 week, 2 weeks, 1 month, 2 months and 6 months post-application. The 6-month follow-up of the study was completed with 48 patients (16 patients for each study group). At each follow-up visit, air-stimulated VAS and Schiff scale measurements were employed to quantify hypersensitivity levels.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. No reported or clinically detected dentin hypersensitivity prior to the initiation of non-surgical periodontal therapy.
- •2. Presence of at least five teeth with probing pocket depths (PPD) ≥6 mm.
- •Systemically healthy individuals with no history of systemic diseases that may interfere with periodontal outcomes.
- •4. Absence of deep restorations or visible cracks in the teeth adjacent to those selected for hypersensitivity evaluation.
- •5. No previous treatment for dentin hypersensitivity and no current use of desensitizing toothpaste or products.
- •6. Clinical diagnosis of Stage III or IV periodontitis, involving periodontal support loss in more than 30% of teeth.
- •7. A clinical attachment level (CAL) ≥5 mm and radiographic evidence of bone loss extending to the mid-root level.
- •8. Age 18 years or older at the time of enrollment
排除标准
- •1. Use of antibiotics or analgesic medications at the time of screening or during the course of the study.
- •2. Pregnancy or breastfeeding.
- •Receipt of periodontal therapy within the preceding 6 months.
- •Smoking history of 10 or more cigarettes per day.
- •Regular use of desensitizing toothpaste or other anti-hypersensitivity agents.
- •6. Presence of parafunctional oral habits (e.g., bruxism, clenching).
- •Existence of non-carious cervical lesions such as erosion, attrition, or abrasion on study or adjacent teeth.
- •8. High frequency of acidic dietary intake.
- •Inability to meet hypersensitivity perception thresholds following non-surgical periodontal therapy, defined as a Visual Analog Scale (VAS) score >4 and Schiff Cold Air Sensitivity Scale score of 2 or
- •10. Contraindications to the use of Er,Cr:YSGG laser therapy, including but not limited to: known allergies to local or topical anesthetics, presence of cardiac devices (e.g., pacemakers or implantable defibrillators), respiratory disease, bleeding disorders, or immunosuppressive conditions. In such cases, written clearance from a physician is required.
- •11. Known or suspected allergy to any component of the Gluma Desensitizer, specifically hydroxymethyl methacrylate or glutaraldehyde.
研究组 & 干预措施
Gluma applied group
Participants received Gluma Desensitizer (containing glutaraldehyde) applied to the sensitive teeth. Following isolation of the target teeth with cotton rolls, Gluma was applied using a microbrush in a rubbing motion for 30 seconds. The dentin surface was then air-dried until it lost its shine, followed by rinsing with water for 60 seconds.
laser applied group
Participants received Er,Cr:YSGG laser treatment (Water-Lase iPlusTM; Biolase® Technology Inc., Irvine, CA, USA). Laser parameters were set as follows: 2780 nm wavelength, 0.25 W power, 20 Hz frequency, 140 μs pulse duration, and 30 seconds exposure time. The MZ6 tip (660 μm diameter, 6 mm length, 1 mm spot size) was used in non-contact mode from a 1 mm distance, perpendicular to the dentin surface, with 0% water and 10% air spray. All laser applications followed international safety standards and protocols.
干预措施: Er,Cr:YSGG laser (Device)
Combination applied group
Participants in this group received both treatments: Gluma was applied using the same method as in Gluma, followed by Er,Cr:YSGG laser therapy using the same parameters and technique as in laser.
干预措施: Gluma Desensitizer and ER:CR;YSGG laser combination (Combination Product)
结局指标
主要结局
Decrease in hypersensitivity rate
时间窗: 6 months
Combination of Gluma and Laser application can have an synergistic effect on hypersensitivity rate
次要结局
未报告次要终点
研究者
Ece AÇIKGÖZ ALPARSLAN
Assistant professor
Trakya University