RecruitingNot ApplicableNCT07527351

Analysis of the Reliability and Validity of Laser Speckle Contrast Imaging

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


Sponsor

Universidad Complutense de Madrid

Enrollment

24 participants

Start Date

Apr 13, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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

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Interventions

DIAGNOSTIC_TESTLaser 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.


Locations(1)

Complutense University of Madrid

Madrid, Madrid, Spain

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NCT07527351