Analysis of the Reliability and Validity of Laser Speckle Contrast Imaging

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Complutense de Madrid

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18 years or older

Non-smokers

Good systemic health

Good periodontal health

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: LSCI AssessmentExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Healthy gingiva: baseline and 1 week; surgical wound models: baseline, 1 week, 2 weeks, and 1 month

Secondary outcomes

1

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.

Time frame
Baseline assessment
2

Effect of beam angulation on LSCI perfusion values

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

Time frame
Baseline assessment
3

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.

Time frame
Baseline assessment
4

Effect of heart rate change on LSCI perfusion values

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

Time frame
Baseline assessment

Other outcomes

Sponsors and contacts

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