Analysis of the Reliability and Validity of Laser Speckle Contrast Analysis for the Measurement of Gingival Vascularisation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Reproducibility of LSCI perfusion measurements
研究概览
简要总结
This study is designed to validate laser speckle contrast imaging (LSCI) as a non-invasive method for measuring superficial gingival blood perfusion. Accurate assessment of vascularization is essential for understanding periodontal and peri-implant wound healing, yet current clinical methods are limited by subjective interpretation and low reproducibility. Repeated LSCI measurements will be performed in healthy gingival tissues and in tissues undergoing different mucogingival healing patterns, including primary and secondary intention healing. The study will also evaluate factors that may influence perfusion readings, such as angulation, retractors, mirror use, temperature, and heart rate. The primary objective is to determine the reproducibility of LSCI measurements and to support its use as a reliable tool for monitoring oral soft-tissue vascularization and healing.
详细描述
Periodontal and peri-implant soft-tissue wound healing depends on early vascular changes, especially during the inflammatory and proliferative phases. Although several clinical indices are available to evaluate wound healing, these methods are largely subjective, semi-quantitative, and have limited reproducibility. Laser speckle contrast imaging (LSCI) is a non-invasive, contact-free imaging technique that allows real-time assessment of superficial blood perfusion and may provide a more objective method for monitoring oral soft-tissue vascularization during healing.
The purpose of this study is to assess the reliability and validity of LSCI for measuring gingival vascularization in periodontal and peri-implant tissues. The study will evaluate reproducibility in healthy gingival tissues and in tissues undergoing different mucogingival healing patterns, including closed surgical wounds and open palatal donor sites. In addition, the study will assess the effect of potential modifying factors that may influence perfusion measurements, such as type of lip retraction, beam angulation, mirror-based image acquisition, temperature, and heart rate.
LSCI measurements will be performed using the PeriCam PSI NR system (Perimed AB, Stockholm, Sweden). The device uses near-infrared laser light and dedicated software to generate perfusion maps expressed in perfusion units. Measurements will be acquired under standardized conditions, including controlled patient preparation, resting period, constant room conditions, and repeated image acquisition by a calibrated operator in order to minimize motion artifacts and improve reproducibility.
The main analysis will focus on the reproducibility of perfusion measurements using intraclass correlation coefficients for intra- and inter-day reliability. Perfusion values will be analyzed quantitatively, and the study is intended to determine whether this technology can serve as a reliable tool for assessing superficial vascularization and wound-healing dynamics in oral soft tissues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adults aged 18 years or older
- •Non-smokers
- •Good systemic health
- •Good periodontal health
- •No current systemic medication
- •Good oral hygiene
- •For the retrospective surgical component: availability of previously documented clinical records from closed mucogingival surgical wounds or open palatal donor-site wounds, with prior consent allowing use of documented clinical material for research
排除标准
- •Pregnancy
- •Use of anti-inflammatory medication within 7 days before evaluation
- •Oral treatment within 6 months before evaluation
- •For the prospective healthy-gingiva component: any condition not compatible with good systemic or periodontal health
- •For the retrospective surgical component: absence of adequate previously documented clinical records or absence of prior consent for research use of the documented material
研究组 & 干预措施
LSCI Assessment
Participants undergo standardized laser speckle contrast imaging (LSCI) assessments of gingival/peri-implant soft-tissue perfusion under predefined conditions. Repeated measurements are obtained in healthy gingiva and in surgically treated oral soft tissues with different healing patterns, including closed mucogingival wounds and open palatal donor sites. The intervention consists of non-invasive, contact-free perfusion imaging performed with the PeriCam PSI system according to a standardized measurement protocol.
干预措施: Laser Speckle Contrast Imaging (Diagnostic Test)
结局指标
主要结局
Reproducibility of LSCI perfusion measurements
时间窗: Healthy gingiva: baseline and 1 week; surgical wound models: baseline, 1 week, 2 weeks, and 1 month
Reproducibility of superficial gingival/oral soft-tissue perfusion measurements obtained by laser speckle contrast imaging, expressed in perfusion units (PU). Reliability will be assessed using intra-class correlation coefficients (ICC) for repeated measurements under standardized conditions.
次要结局
- Effect of lip retraction method on LSCI perfusion values(Baseline assessment)
- Effect of beam angulation on LSCI perfusion values(Baseline assessment)
- Effect of mirror-based indirect imaging on LSCI perfusion values(Baseline assessment)
- Effect of heart rate change on LSCI perfusion values(Baseline assessment)
- Effect of temperature provocation on LSCI perfusion values(Baseline assessment)
- Change in perfusion values during closed surgical wound healing(Baseline, 1 week, 2 weeks, and 1 month after intervention)
- Change in perfusion values during open palatal wound healing(Baseline, 1 week, 2 weeks, and 1 month after intervention)