Low-level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness at Free Gingival Graft Donor Sites: A Randomised Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Complete Wound Epithelization
研究概览
简要总结
Objective: The aim of this study was to determine the effects of Low Level Laser Therapy (LLLT) on wound healing at Free Gingival Graft donor sites (FGGDS).
Materials and Methods: Forty patients requiring FGG were selected for this randomized controlled double blinded prospective clinical trial. The FGGDS were treated with LLLT and compared with an untreated control group. The Wound Healing Index (WHI), tissue consistency, colour match (CM), and H2O2 bubbling test for the evaluation of complete wound epithelialization (CWE) were recorded at the 3rd, 7th, 14th and 21st days. The pain-burning level, number of analgesics, and bleeding were recorded for 7 days. Donor area soft tissue thickness (TT) was measured at baseline and at the 1st month.
详细描述
Subjects and Study Design This single center, randomized, double blinded, prospective and controlled clinical study was performed to evaluate the healing time, wound epithelialization and post-operative morbidity produced after harvesting FGG from the palate. The wounds were treated with one of the following methods: sterile wet gauze pressure (control) or LLLT (test).
The patients were randomly assigned to one of the groups by the periodontists with the toss of a coin.
Forty patients requiring FGG were selected, and verbal and written informed consent were obtained.
To minimize the differences related to the surgical technique, all surgical procedures were carried out by one experienced clinician.
Pre-Surgical Treatments All selected patients underwent a professional periodontal prophylaxis phase, and all patients were given proper oral hygiene instructions. Patients who had a full mouth plaque score (FMPS)˂20% and a full mouth bleeding score (FMBS)˂20% were included in the study. The patients were assigned to the control or test groups by the coin toss method.
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 (Participant, Investigator)
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
- •The absence of systemic factors (no systemic disease, no coagulation disorders, no medications affecting periodontal status, and no pregnancy or lactation)
- •Patients who had a full mouth plaque score (FMPS)˂20% and a full mouth bleeding score (FMBS)˂20%
- •No periodontal surgery on the experimental site
- •No nauseal reflection
排除标准
- •The presence of systemic disease
- •Bad oral hygiene-
- •The history of periodontal surgery on the experimental site
- •Nauseal reflection
结局指标
主要结局
Complete Wound Epithelization
时间窗: 14th. day after surgery
The 14th day H2O2 Bubbling test results that show Complete Wound Epithelization
次要结局
- Palatal Tissue Thickness(at baseline and at the 1st month)
研究者
Gülbahar Ustaoğlu
Reseach Asistant
Karadeniz Technical University