The Effect of Low-Level Laser Therapy on Patient's Pain and Healing of Palatal Donor Site Following Free Gingival Graft: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- degree of epithelialization
研究概览
简要总结
The aim of this randomized split-mouth design clinical trial is to clinically evaluate the effectiveness of diode laser in the healing of donor site of palate in free gingival graft.
详细描述
Free gingival graft is the most predictable and successful method for increasing the width of keratinized tissue around teeth/dental implants and vestibular deepening. However, patient discomfort during the healing time is a major disadvantage of this procedure. Several methods have been introduced to accelerate the healing time and reduction of patient's pain during first days after surgery. Low-level lasers have shown promising results in biostimulation of cell growth and differentiation in cultures. However, there are lack of well designed double blind placebo controlled randomized controlled clinical studies evaluating the effects of Low-level laser therapy in acceleration of wound healing and pain relief of patients undergoing free gingival grafts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lack of keratinized tissue around teeth (bilateral)
排除标准
- •patients with systemic diseases
- •non-cooperative patients
- •poor oral hygiene
- •root surface restorations or active caries
研究组 & 干预措施
low-level laser therapy
Low-level laser (Diode, 66o nanometer, power:200 milli Watt (mW), Continuous wave, time of irradiation:32 seconds)is irradiated in donor site
干预措施: Low-level laser therapy (Radiation)
Turned-off laser
The same protocol is applied in te donor site, unless the laser is remained off.
干预措施: Turned-off laser (Radiation)
结局指标
主要结局
degree of epithelialization
时间窗: At day 21
3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling * Complete epithelialization: bubble was not seen * Partial epithelialization: bubbles were seen in lesser than half of donor site * No epithelialization: bubble were seen in more than half of donor site
degree of epithelialization
时间窗: At day 7
3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling * Complete epithelialization: bubble was not seen * Partial epithelialization: bubbles were seen in lesser than half of donor site * No epithelialization: bubble were seen in more than half of donor site
degree of epithelialization
时间窗: At day 14
3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling * Complete epithelialization: bubble was not seen * Partial epithelialization: bubbles were seen in lesser than half of donor site * No epithelialization: bubble were seen in more than half of donor site
次要结局
- Visual analogue scale (VAS) pain score(at day 14)
- Clinical healing(at day 21)
- Visual analogue scale (VAS) pain score(at day 1)
- Visual analogue scale (VAS) pain score(at day 2)
- Visual analogue scale (VAS) pain score(at day 3)
- Visual analogue scale (VAS) pain score(at day 4)
- Visual analogue scale (VAS) pain score(at day 5)
- Visual analogue scale (VAS) pain score(at day 6)
- Visual analogue scale (VAS) pain score(at day 7)
- Clinical healing(at day 1)
- Clinical healing(at day 2)
- Clinical healing(at day 7)
- Clinical healing(at day 14)
研究者
Neda Moslemi
Assistant Professor
Tehran University of Medical Sciences