Analysis of the Reliability and Validity of Laser Speckle Contrast Imaging

Официальное название

Analysis of the Reliability and Validity of Laser Speckle Contrast Analysis for the Measurement of Gingival Vascularisation

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Laser Speckle Contrast Imaging
  Laser speckle contrast imaging is a non-invasive, contact-free diagnostic imaging method used to assess superficial blood perfusion in gingival and oral soft tissues. In this study, standardized LSCI measurements are performed to evaluate gingival vascularization in healthy tissues and in surgically treated tissues with different healing patterns, including closed mucogingival wounds and open palatal donor sites. Measurements are obtained under controlled conditions using the PeriCam PSI system

Первичные конечные точки

• Reproducibility of LSCI perfusion measurements [Срок оценки: Healthy gingiva: baseline and 1 week; surgical wound models: baseline, 1 week, 2 weeks, and 1 month]

Вторичные конечные точки (7)

• Effect of lip retraction method on LSCI perfusion values [Срок оценки: Baseline assessment]
• Effect of beam angulation on LSCI perfusion values [Срок оценки: Baseline assessment]
• Effect of mirror-based indirect imaging on LSCI perfusion values [Срок оценки: Baseline assessment]
• Effect of heart rate change on LSCI perfusion values [Срок оценки: Baseline assessment]
• Effect of temperature provocation on LSCI perfusion values [Срок оценки: Baseline assessment]
• Change in perfusion values during closed surgical wound healing [Срок оценки: Baseline, 1 week, 2 weeks, and 1 month after intervention]
• Change in perfusion values during open palatal wound healing [Срок оценки: Baseline, 1 week, 2 weeks, and 1 month after intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Испания · 1 центр

• Complutense University of Madrid — Madrid

Идентификаторы

NCT: NCT07527351 · Speckle

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗