Analysis of the Reliability and Validity of Laser Speckle Contrast Imaging (LSCI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gingival Vascularization; Oral Soft Tissue Wound Healing; Laser Speckle Contrast Imaging; Periodontal Wound Healing
• Intervention / Treatment: Diagnostic test: Laser Speckle Contrast Imaging

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariano Sanz Alonso, DMD, MD, PHD; Phone Number: 913942021; Email: marsan@ucm.es
• Study Contact Backup: Name: Mercedes Lopez Duran, DMD, PHD

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28040
      • Recruiting
      • Complutense University of Madrid
      • Contact: Andrea Dobos, DMD; Phone Number: +36309532140; Email: andobos@ucm.es
      • Contact: Mercedes Lopez Duran, DMD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Diagnostic test: 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 to assess reproducibility and the influence of predefined measurement-related factors on perfusion values.; Other Names: LSCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Mariano Sanz Alonso, DMD, MD, PHD, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Reliability; Reproducibility; LSCI; Mucogingival surgery; Periodontal wound healing; Laser speckle contrast imaging; Palatal donor site; Gingival microcirculation; Oral soft tissue wound healing; Blood perfusion; PeriCam PSI
• Additional Relevant MeSH Terms: Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Optical Imaging; Laser Speckle Contrast Imaging
• Other Study ID Numbers: Speckle

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No