Analysis of the Reliability and Validity of Laser Speckle Contrast Imaging
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laser Speckle Contrast Imaging.
- Who it may be relevant to
- Registry conditions: Gingival Vascularization, Oral Soft Tissue Wound Healing, Laser Speckle Contrast Imaging, Periodontal Wound Healing. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Analysis of the Reliability and Validity of Laser Speckle Contrast Analysis for the Measurement of Gingival Vascularisation
Overview
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.
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.
Interventions
- 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
Primary outcome measures
- Reproducibility of LSCI perfusion measurements [Time frame: Healthy gingiva: baseline and 1 week; surgical wound models: baseline, 1 week, 2 weeks, and 1 month]
Secondary outcome measures (7)
- Effect of lip retraction method on LSCI perfusion values [Time frame: Baseline assessment]
- Effect of beam angulation on LSCI perfusion values [Time frame: Baseline assessment]
- Effect of mirror-based indirect imaging on LSCI perfusion values [Time frame: Baseline assessment]
- Effect of heart rate change on LSCI perfusion values [Time frame: Baseline assessment]
- Effect of temperature provocation on LSCI perfusion values [Time frame: Baseline assessment]
- Change in perfusion values during closed surgical wound healing [Time frame: Baseline, 1 week, 2 weeks, and 1 month after intervention]
- Change in perfusion values during open palatal wound healing [Time frame: Baseline, 1 week, 2 weeks, and 1 month after intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Spain · 1 center
- Complutense University of Madrid — Madrid
Identifiers
NCT: NCT07527351 · Speckle