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NCT Number: NCT07527351

Analysis of the Reliability and Validity of Laser Speckle Contrast Imaging

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complutense University of Madrid

Madrid, 28040, Spain

Location status: Recruiting

Location contact

Andrea Dobos, DMD

CONTACT

[email protected]

+36309532140

Mercedes Lopez Duran, DMD, PHD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: LSCI

Primary outcomes

  1. Reproducibility of LSCI perfusion measurements

    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.

Secondary outcomes

  1. Effect of lip retraction method on LSCI perfusion values

    Time frame: Baseline assessment

    Difference in perfusion values (PU) between measurements obtained using a plastic lip retractor and a dental mirror under resting conditions.

  2. Effect of beam angulation on LSCI perfusion values

    Time frame: Baseline assessment

    Difference in perfusion values (PU) between perpendicular and angulated measurements.

  3. Effect of mirror-based indirect imaging on LSCI perfusion values

    Time frame: Baseline assessment

    Difference in perfusion values (PU) between direct and mirror-reflected indirect measurements of the same region of interest.

  4. Effect of heart rate change on LSCI perfusion values

    Time frame: Baseline assessment

    Difference in perfusion values (PU) before and after exercise-induced increase in heart rate.

  5. Effect of temperature provocation on LSCI perfusion values

    Time frame: Baseline assessment

    Difference in perfusion values (PU) after hot- and cold-water oral rinsing compared with reference measurements.

  6. Change in perfusion values during closed surgical wound healing

    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.

  7. Change in perfusion values during open palatal wound healing

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariano Sanz Alonso, DMD, MD, PHD

CONTACT

[email protected]

913942021

Mercedes Lopez Duran, DMD, PHD

CONTACT

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Acronym: LSCI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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