Effect of Gallium-Aluminum-Arsenide Laser - AsGaAl Low-level Laser Therapy on the Healing of Human Palate Mucosa After Connective Tissue Graft Harvesting: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in the Remaining wound area (RWA)
研究概览
简要总结
The aim of the present study was to evaluate the influence of LLLT on the recovery of the palatine donor site wounds after harvest connective tissue graft.
详细描述
This was a prospective, parallel and controlled clinical trial. The population evaluated in this study was selected at Science and Technology Institute - ICT - São José dos Campos, College of Dentistry
The selected patients were randomly allocated (by a computer generated list) into:
- Group 1 (Test, n=16): Periodontal surgery for root coverage through connective tissue graft and LLLT on donor site.
- Group 2 (Control, n=16): Periodontal surgery for root coverage through connective tissue graft and LLLT SHAM on donor site.
Surgical procedure was performed by one surgeon. The gingival recession defects were treated by connective tissue graft technique. A connective tissue graft was removed from palate mucosa following Bruno technique. Briefly, a first incision on the palate was performed perpendicularly to the long axis of the teeth, 2 to 3 mm apical to the gingival margin. The mesiodistal length of the incision was determined by the length of the graft required to cover the recession. Since the selected recessions were in maxillary canines and premolars, the length of the graft vary minimally (10-12mm). The second incision was made parallel to the first one, 1-2mm apically, and parallel to the long axis of the teeth in order to separate the subepithelium connective tissue from the epithelial layer. The incision is carried far enough apically to provide a 7mm height of connective tissue to cover the denuded root surface. Afterwards, another incision parallel to the long axis of the teeth, starting from the first incision was performed to separate the subepithelium connective tissue from the periosteum. Then, the connective tissue graft was removed from the palate as atraumatically as possible. Single sutures were made on the palate (4-0 silk) and the graft was sutured on the receptor site
Clinical parameters were assessed at baseline and 7, 14, 45, 60 and 90 days post-operatively
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients that were 20 to 70 years old, both genders; presenting gingival recession Class I or II Miller, on vital canines or pre-molars, palatine region (donor site) with no pathological or morphological alterations; patients who agreed with and signed the formal consent to participate in the study, after receiving an explanation of risks and benefits, by an individual who was not a member of the present study (Resolution no. 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO 179/93).
排除标准
- •Patients with systemic problems that contraindicated surgical procedure; patients under medication that would interfere with the wound healing; patients who smoked; patients who were pregnant or lactating; patients who had had periodontal surgery on the study area.
研究组 & 干预措施
Low-level laser therapy (LLLT) Sham
LLLT Sham on the palatal donor site of connective tissue graft
干预措施: LLLT (Procedure)
Low-level laser therapy (LLLT)
LLLT on the palatal donor site of connective tissue graft
干预措施: LLLT (Procedure)
结局指标
主要结局
Change in the Remaining wound area (RWA)
时间窗: 7, 14, 45 and 60 post-operative days
For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. Theses photographs were exported to image software (Image J - NIH, Bethesda, USA) and the wound area was measured in square millimeters
次要结局
- Post-operative discomfort(7, 14, 45 and 60 days after surgical procedure)
研究者
Mauro Pedrine Santamaria
Researcher - Principal investigator
UPECLIN HC FM Botucatu Unesp