Laser-Assisted Pontic Site Soft Tissue Healing Prior to Fixed Partial Denture Rehabilitation: A Randomized Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Clinical healing index (Landry, Turnbull and Howley Healing Index)
研究概览
简要总结
This randomized placebo-controlled clinical trial aimed to evaluate the effect of laser-assisted therapy on soft tissue healing at the pontic site prior to fixed partial denture rehabilitation. Clinical healing outcomes, postoperative pain levels, and gingival crevicular fluid transforming growth factor beta-2 (TGF-β2) levels were assessed to determine the biological and clinical effects of laser therapy compared with placebo.
详细描述
Delayed or compromised soft tissue healing at the pontic site may prolong prosthetic treatment and negatively affect tissue stability and patient comfort. Photobiomodulation has been reported to enhance wound healing and modulate inflammatory and regenerative processes. This randomized placebo-controlled clinical trial evaluated the clinical and biological effects of laser-assisted therapy on pontic site healing prior to fixed partial denture rehabilitation. Clinical healing index scores, wound dimensions, postoperative pain levels, and gingival crevicular fluid TGF-β2 levels were assessed to investigate both clinical and biological aspects of healing.
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
- Single (Participant)
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
- •Adults aged 18 years or older
- •Patients requiring single-tooth extraction followed by fixed partial denture rehabilitation
- •Patients in good general health
- •Patients willing to participate and able to provide informed consent
排除标准
- •Presence of systemic diseases that may affect wound healing (e.g., uncontrolled diabetes, immunological disorders)
- •Active periodontal disease at the study site
- •Use of medications affecting wound healing
- •Smoking or tobacco use
- •Pregnancy or lactation
- •History of radiotherapy in the head and neck region
- •Known contraindications to laser therapy
研究组 & 干预措施
GRR Laser
Laser therapy applied once daily for five consecutive days following tooth extraction.
干预措施: GRR laser (Device)
Nd:YAG Laser
Nd:YAG laser therapy applied once daily for five consecutive days following tooth extraction.
干预措施: Nd:YAG laser (Device)
Placebo
Sham laser application performed under identical conditions without energy delivery.
干预措施: Sham laser (Other)
结局指标
主要结局
Clinical healing index (Landry, Turnbull and Howley Healing Index)
时间窗: Baseline, Day 7, Day 14
Clinical healing was assessed using the Landry, Turnbull and Howley Healing Index, which provides a single composite ordinal score ranging from 1 to 5, where higher scores indicate better soft tissue healing. The score is determined based on clinical evaluation of tissue color, bleeding on palpation, presence of granulation tissue, and degree of epithelialization at the pontic site.
次要结局
- Wound size reduction(Baseline, Day 7, Day 14)
- Postoperative pain (VAS)(Baseline, Day 7, Day 14)
- Gingival crevicular fluid TGF-β2 levels(Baseline, Day 7, Day 14)
研究者
İREM KARAGOZOGLU
Assist.prof.
University of Gaziantep