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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSCI Assessment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Speckle Contrast Imaging | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of LSCI perfusion measurements | 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. | Healthy gingiva: baseline and 1 week; surgical wound models: baseline, 1 week, 2 weeks, and 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of lip retraction method on LSCI perfusion values | Difference in perfusion values (PU) between measurements obtained using a plastic lip retractor and a dental mirror under resting conditions. | Baseline assessment |
| Effect of beam angulation on LSCI perfusion values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariano Sanz Alonso, DMD, MD, PHD | Contact | 913942021 | marsan@ucm.es | |
| Mercedes Lopez Duran, DMD, PHD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Mariano Sanz Alonso, DMD, MD, PHD | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complutense University of Madrid | Recruiting | Madrid | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D000081982 | Laser Speckle Contrast Imaging |
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Single-group interventional study in which participants undergo standardized laser speckle contrast imaging (LSCI) assessments to evaluate gingival perfusion under predefined conditions. Repeated measurements are obtained in healthy gingival tissues and in surgically treated oral soft tissues with different healing patterns, including closed mucogingival wounds and open palatal donor sites. The study assesses measurement reproducibility and the effect of predefined modifying factors on perfusion readings.
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Difference in perfusion values (PU) between perpendicular and angulated measurements. |
| Baseline assessment |
| Effect of mirror-based indirect imaging on LSCI perfusion values | Difference in perfusion values (PU) between direct and mirror-reflected indirect measurements of the same region of interest. | Baseline assessment |
| Effect of heart rate change on LSCI perfusion values | Difference in perfusion values (PU) before and after exercise-induced increase in heart rate. | Baseline assessment |
| Effect of temperature provocation on LSCI perfusion values | Difference in perfusion values (PU) after hot- and cold-water oral rinsing compared with reference measurements. | Baseline assessment |
| Change in perfusion values during closed surgical wound healing | Perfusion values (PU) and percentage change from baseline in closed mucogingival surgical wounds over time. | Baseline, 1 week, 2 weeks, and 1 month after intervention |
| Change in perfusion values during open palatal wound healing | Perfusion values (PU) and percentage change from baseline in open palatal donor-site wounds over time. | Baseline, 1 week, 2 weeks, and 1 month after intervention |
| D008919 |
| Investigative Techniques |