Complutense University of Madrid
Madrid, 28040, Spain
Location status: Recruiting
NCT Number: NCT07527351
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Madrid, 28040, Spain
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 to assess reproducibility and the influence of predefined measurement-related factors on perfusion values.
Other names: LSCI
Time frame: 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.
Time frame: Baseline assessment
Difference in perfusion values (PU) between measurements obtained using a plastic lip retractor and a dental mirror under resting conditions.
Time frame: Baseline assessment
Difference in perfusion values (PU) between perpendicular and angulated measurements.
Time frame: Baseline assessment
Difference in perfusion values (PU) between direct and mirror-reflected indirect measurements of the same region of interest.
Time frame: Baseline assessment
Difference in perfusion values (PU) before and after exercise-induced increase in heart rate.
Time frame: Baseline assessment
Difference in perfusion values (PU) after hot- and cold-water oral rinsing compared with reference measurements.
Time frame: Baseline, 1 week, 2 weeks, and 1 month after intervention
Perfusion values (PU) and percentage change from baseline in closed mucogingival surgical wounds over time.
Time frame: Baseline, 1 week, 2 weeks, and 1 month after intervention
Perfusion values (PU) and percentage change from baseline in open palatal donor-site wounds over time.
Contact information is provided by the study sponsor or research team.
Mariano Sanz Alonso, DMD, MD, PHD
CONTACT
Mercedes Lopez Duran, DMD, PHD
CONTACT
Universidad Complutense de Madrid
Other
Analysis of the Reliability and Validity of Laser Speckle Contrast Analysis for the Measurement of Gingival Vascularisation
Acronym: LSCI
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