Free Gingival Graft Adjunct With Low Level Laser Therapy: A Randomized Placebo- Controlled Parallel Group Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Graft shrinkage
研究概览
简要总结
The present placebo-controlled parallel design clinical study was planned to determine the effect of low level laser therapy on clinical periodontal conditions and dimensions of free gingival graft as well as postoperative pain levels in the surgical area.
详细描述
Background: Shrinkage of the free gingival graft (FGG) and patient's discomfort during healing period are important concerns. Therefore, this study aimed to evaluate the effect of low level laser therapy (LLLT) in terms of enhancing wound healing, reducing graft shrinkage and postoperative pain.
Methods: Thirty patients were randomly assigned to receive either FGG+ LLLT (test, n = 15) or FGG + placebo LLLT (control, n = 15). In the test group, a diode laser (aluminum-gallium-arsenide, 810 nm, 0.1 W, continuous mode, time of irradiation:60 s, energy density: 6 J/cm2, spot size:0.5 cm) was applied immediately after the FGG surgery and 1,3,7, and 14 days later. The control group received the same sequence of irradiation with the laser-off. Comparison of the graft surface areas between groups at 1st, 3rd and 6th months were made with an image-analyzing software. Complete wound epithelization, visual analogue scale (VAS) pain score of recipient site and the number of analgesic used were evaluated after the surgery.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients >18 years old
- •Patients presenting Class I or II Miller gingival recession on vital incisors in the mandibular anterior region with no caries or restoration
- •The included teeth had also keratinized gingiva <2 mm; PI and GI<
- •The patients had to be systemically healthy and non-smokers.
排除标准
- •Patients presenting active periodontal disease and probing depth >3 mm; taking medications that would interfere with the wound-healing process or that contraindicate the surgical procedure;
- •Pregnant or lactating women;
- •Patients who underwent periodontal surgery in the study area;
- •Patients with orthodontic therapy in progress were excluded.
研究组 & 干预措施
Test group
Free Gingival Graft (FGG) + Low Level Laser Therapy (LLLT) + Clinical Examination
The test group received LLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) at the FGG sites with a wavelength of 810 nm and output power of 0.1 W, for 60 s, with an energy density of 6 J/cm2 in the continuous wave mode (spot size:0.5 cm). The laser beam was directed perpendicularly toward the tissue in the noncontact mode. The laser was irradiated at the recipient sites immediately after surgery and 1, 3, 7, and 14 days later.
干预措施: CheseeTM Diode Laser (Device)
Test group
Free Gingival Graft (FGG) + Low Level Laser Therapy (LLLT) + Clinical Examination
The test group received LLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) at the FGG sites with a wavelength of 810 nm and output power of 0.1 W, for 60 s, with an energy density of 6 J/cm2 in the continuous wave mode (spot size:0.5 cm). The laser beam was directed perpendicularly toward the tissue in the noncontact mode. The laser was irradiated at the recipient sites immediately after surgery and 1, 3, 7, and 14 days later.
干预措施: Clinical examination (Other)
Control group
Free Gingival Graft (FGG)+Placebo Low Level Laser Therapy (PLLLT) + Clinical Examination
The control group received PLLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) same as test group without pushing the start button
干预措施: CheseeTM Diode Laser (Device)
Control group
Free Gingival Graft (FGG)+Placebo Low Level Laser Therapy (PLLLT) + Clinical Examination
The control group received PLLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) same as test group without pushing the start button
干预措施: Clinical examination (Other)
结局指标
主要结局
Graft shrinkage
时间窗: 1-, 3-, and 6-months after FGG surgery
The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months.
次要结局
- Epithelization(7, 14, 21, and 28 days after FGG surgery)
研究者
Sadiye Gunpinar
Asst. Prof. Dr.
Abant Izzet Baysal University