Impact of Nd: YAG Laser Photobiostimulation on Healing of Gingiva Following Tooth Extraction and Alveolar Ridge Preservation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Inflammatory markers in saliva
研究概览
简要总结
The intervention in this study is to determine whether multiple applications of photobiostimulation with Nd-YAG laser improve wound healing following tooth extraction and alveolar ridge preservation. Investigators plan to assess the impact of laser treatment on wound healing by measuring salivary biomarkers, gingival wound size and surveying for the use of pain reduction and patient satisfaction. The intervention group will receive extraction and alveolar ridge preservation with Nd-YAG laser photobiostimulation on days 1, 3, and 7 following extraction and socket preservation, while the control group will receive the standard of care extraction and alveolar ridge preservation without the laser
详细描述
Photobiostimulation, also known as low-level laser therapy (LLLT) or phototherapy, utilizes a low-level laser to increase cell proliferation, enhance cell stimulation, and reduce gingival inflammation. It has been reported that photobiostimulation enhances chemical and metabolic changes and alters cellular behavior in the tissue by light absorption. Photobiostimulation as an adjunct treatment modality can accelerate the healing process, improve patient comfort and satisfaction following dental surgical procedures, and benefit patients with compromised healing capacity.
Alveolar ridge preservation (ARP) is a standard procedure to minimize alveolar bone and gingival soft tissue atrophy following tooth extraction and before dental implant placement. The healing of ARP is critical for the success of implant placement timely treatment. The ARP procedure is currently the standard practice for patients interested in dental implant treatment and involves bone grafting of the extracted socket. ARP techniques have been used for over 20 years to maintain a favorable soft and hard tissue morphology for dental implant-related restorations.
The purpose of this study is to understand the impact of Nd-YAG laser photobiostimulation on wound healing when combined with tooth extraction and alveolar ridge preservation procedures.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are ≥ 18 years old,
- •Patients who are scheduled for the treatment of tooth extraction and alveolar ridge preservation (ARP)
- •No contraindications for tooth extraction and alveolar ridge preservation based on electronic health records.
- •Participants who can express the level of pain
- •Participants who self-report "not pregnant"
排除标准
- •Untreated periodontal disease
- •Acute infection of the teeth
- •Use of antibiotics within the last three months.
- •Pregnant or lactating women
- •Use of bisphosphonates based on EHR
- •Alveolar bone defects occurred or were detected during tooth extraction
研究组 & 干预措施
Control
Sham laser will be applied instead of the low-level laser.
Intervention
Low-level lase therapy will be applied at tooth extraction sites.
干预措施: Low-level laser therapy (Other)
结局指标
主要结局
Inflammatory markers in saliva
时间窗: From day of tooth extraction through day 7
The measurement of inflammatory and anti-inflammatory markers in saliva, IL-1β, IL-6, IL-8, IL-10, IL-12 and TNF secreted during the early stages of wound healing at day 3 and day 7.
Wound size dimensional changes
时间窗: From the day of tooth extraction to day 42
The comparison of dimensional changes in wound size between test and intervention groups. Digital gingival scans of the wound will be taken immediately after surgery and at days 3, 7, 14, and 42 for Aim 2.
Post-operative pain
时间窗: From post-operative day 3 to day 14
Recording of pain perception using a Visual Analog Scale at visits 3, 7, and 14 (maximum pain being 10 vs. no pain being 0), 2)
次要结局
未报告次要终点