Analysis of the Reliability and Validity of Laser Speckle Contrast Imaging

NCT07527351 | Recruiting

• 1 other identifier: Speckle
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Vascularization; Oral Soft Tissue Wound Healing; Laser Speckle Contrast Imaging; Periodontal Wound Healing

Keywords

Laser speckle contrast imaging; LSCI; Gingival microcirculation; Oral soft tissue wound healing; Periodontal wound healing; Mucogingival surgery; Palatal donor site; Blood perfusion; Reproducibility; Reliability; PeriCam PSI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

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.

Diagnostic Test: Laser Speckle Contrast Imaging

Interventions

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.

Also known as: LSCI

LSCI Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Complutense University of Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

MeSH Terms

Interventions

Laser Speckle Contrast Imaging

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Mariano Sanz Alonso, DMD, MD, PHD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariano Sanz Alonso, DMD, MD, PHD

CONTACT

913942021; marsan@ucm.es

Mercedes Lopez Duran, DMD, PHD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: April 13, 2026
• Primary Completion: May 20, 2026
• Study Completion: May 20, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)