Checking how well laser speckle contrast imaging measures gum blood flow
Analysis of the Reliability and Validity of Laser Speckle Contrast Analysis for the Measurement of Gingival Vascularisation
We will test whether laser speckle contrast imaging (LSCI) can reliably measure superficial gum blood flow in healthy adults and in people healing after periodontal or implant-related soft-tissue surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07527351 on ClinicalTrials.gov |
What this trial studies
This interventional project will use the PeriCam PSI NR LSCI device to acquire repeated, contact-free perfusion maps of superficial gingival tissues in adults. Measurements will be taken prospectively in healthy gingiva and retrospectively from documented mucogingival surgical wounds, including closed surgical sites and open palatal donor sites, to compare reproducibility across healing patterns. Standardized patient preparation and imaging protocols will be used while systematically testing the influence of beam angulation, lip retractors, mirror use, temperature, and heart rate on perfusion readings. The primary aim is to determine the reproducibility and validity of LSCI measurements to support its use for monitoring oral soft-tissue vascularization during healing.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) who do not smoke and are in good systemic and periodontal health for the healthy-gingiva arm, or patients with previously documented closed mucogingival or palatal donor-site wounds with prior consent for the retrospective arm.
Not a fit: People who smoke, are pregnant, have taken anti-inflammatory medication within seven days, have had oral treatment within six months, or have poor systemic or periodontal health are unlikely to qualify or receive benefit from participation.
Why it matters
Potential benefit: If successful, LSCI could give clinicians a fast, objective, non-contact way to monitor gum blood flow and healing, enabling earlier detection of healing problems and more tailored care.
How similar studies have performed: LSCI has been used successfully to measure superficial microcirculation in other medical fields, but its application to gingival perfusion and periodontal wound monitoring is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madrid, Madrid
- Complutense University of Madrid — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Mariano Sanz Alonso, DMD, MD, PHD — Universidad Complutense de Madrid
- Study coordinator: Mariano Sanz Alonso, DMD, MD, PHD
- Email: marsan@ucm.es
- Phone: 913942021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.