Gingival VascularizationLSCINCT07527351
Analysis of the Reliability and Validity of Laser Speckle Contrast Imaging
A study testing Laser Speckle Contrast Imaging in people with Gingival Vascularization and Oral Soft Tissue Wound Healing, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Vascularization, Oral Soft Tissue Wound Healing, Laser Speckle Contrast Imaging
- What is being tested?
- Laser Speckle Contrast Imaging
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 13 Apr 2026to 20 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mercedes Lopez Duran, DMD, PHD contact
Spain1 site, 1 recruiting
- Recruiting
Complutense University of Madrid
Madrid, Madrid, 28040
Andrea Dobos, DMD, +36309532140, andobos@ucm.es
Mercedes Lopez Duran, DMD, PHD
About this study
Official title: Analysis of the Reliability and Validity of Laser Speckle Contrast Analysis for the Measurement of Gingival Vascularisation
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.
Read the 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.
- Conditions
- Gingival Vascularization, Oral Soft Tissue Wound Healing, Laser Speckle Contrast Imaging, Periodontal Wound Healing
- Being tested
- Laser Speckle Contrast Imaging
- Keywords
- Laser speckle contrast imaging, LSCI, Gingival microcirculation, Oral soft tissue wound healing, Periodontal wound healing, Mucogingival surgery, Palatal donor site, Blood perfusion, Reproducibility, Reliability, PeriCam PSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Speckle Contrast ImagingDiagnostic test
Also called LSCI
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.
| Study group | Role | What they receive |
|---|---|---|
| LSCI Assessment | Experimental | Participants undergo standardized laser speckle contrast imaging (LSCI) assessments of gingival/peri-implant soft-tissue perfusion under predefined conditions. Repeated measurements are obtained in healthy gingiva and in surgically treated oral soft tissues with different healing patterns, including closed mucogingival wounds and open palatal donor sites. The intervention consists of non-invasive, contact-free perfusion imaging performed with the PeriCam PSI system according to a standardized measurement protocol. Receives: Diagnostic Test: Laser Speckle Contrast Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Healthy gingiva: baseline and 1 week; surgical wound models: baseline, 1 week, 2 weeks, and 1 month
Secondary outcomes (7)
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.
Measured: Baseline assessment
Effect of beam angulation on LSCI perfusion values
Difference in perfusion values (PU) between perpendicular and angulated measurements.
Measured: Baseline assessment
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.
Measured: Baseline assessment
Effect of heart rate change on LSCI perfusion values
Difference in perfusion values (PU) before and after exercise-induced increase in heart rate.
Measured: Baseline assessment
Effect of temperature provocation on LSCI perfusion values
Difference in perfusion values (PU) after hot- and cold-water oral rinsing compared with reference measurements.
Measured: Baseline assessment
Change in perfusion values during closed surgical wound healing
Perfusion values (PU) and percentage change from baseline in closed mucogingival surgical wounds over time.
Measured: Baseline, 1 week, 2 weeks, and 1 month after intervention
Change in perfusion values during open palatal wound healing
Perfusion values (PU) and percentage change from baseline in open palatal donor-site wounds over time.
Measured: Baseline, 1 week, 2 weeks, and 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start13 Apr 2026
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival VascularizationStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group interventional study in which participants undergo standardized laser speckle contrast imaging (LSCI) assessments to evaluate gingival perfusion under predefined conditions. Repeated measurements are obtained in healthy gingival tissues and in surgically treated oral soft tissues with different healing patterns, including closed mucogingival wounds and open palatal donor sites. The study assesses measurement reproducibility and the effect of predefined modifying factors on perfusion readings.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Sanz Alonso, DMD, MD, PHD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527351
- Sponsor's protocol ID
- Speckle
- Acronym
- LSCI
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Reliability and Validity of Laser Speckle Contrast Analysis for the Measurement of Gingival Vascularisation
- ClinicalTrials.gov ID
- NCT07527351
- Acronym / sponsor ID
- LSCI / Speckle
- Conditions
- Gingival Vascularization, Oral Soft Tissue Wound Healing, Laser Speckle Contrast Imaging, Periodontal Wound Healing
- Keywords
- Laser speckle contrast imaging, LSCI, Gingival microcirculation, Oral soft tissue wound healing, Periodontal wound healing, Mucogingival surgery, Palatal donor site, Blood perfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group interventional study in which participants undergo standardized laser speckle contrast imaging (LSCI) assessments to evaluate gingival perfusion under predefined conditions. Repeated measurements are obtained in healthy gingival tissues and in surgically treated oral soft tissues with different healing patterns, including closed mucogingival wounds and open palatal donor sites. The study assesses measurement reproducibility and the effect of predefined modifying factors on perfusion readings.
| Arm | Type | Receives |
|---|---|---|
| LSCI Assessment | Experimental | Diagnostic Test: Laser Speckle Contrast ImagingParticipants undergo standardized laser speckle contrast imaging (LSCI) assessments of gingival/peri-implant soft-tissue perfusion under predefined conditions. Repeated measurements are obtained in healthy gingiva and in surgically treated oral soft tissues with different healing patterns, including closed mucogingival wounds and open palatal donor sites. The intervention consists of non-invasive, contact-free perfusion imaging performed with the PeriCam PSI system according to a standardized measurement protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or older
- Non-smokers
- Good systemic health
- Good periodontal health
- No current systemic medication
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Speckle Contrast ImagingAlso: LSCILaser 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. | Diagnostic test | LSCI Assessment |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Gingival Vascularization
Recruiting
Theravex Oral and Theravex Tissue Care Plus in the Healing Process of Mucogingival Surgery
Gingival Recession, Localized
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mercedes Lopez Duran, DMD, PHD contact
Mariano Sanz Alonso, DMD, MD, PHD principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Speckle Contrast Imaging in people with Gingival Vascularization and Oral Soft Tissue Wound Healing, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariano Sanz Alonso, DMD, MD, PHD (913942021, marsan@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of LSCI perfusion measurements (time frame: Healthy gingiva: baseline and 1 week; surgical wound models: baseline, 1 week, 2 weeks, and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.