Gingival RecessionLASCAMNCT02540590
Post-operative Blood Flow Measurements of the Oral Mucosa
An observational study of Gingival Recession, run by Semmelweis University at 1 site in Hungary.
Trial summary
Our overall goal is to characterize the role of the microcirculation in healing oral mucosa after routinely applied surgery intervention in order to facilitate treatment. Using Laser Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators will have the possibility to detect functional… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- laser speckle contrast imaging of the oral mucosa and wound fluid measurement
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 8 participants
- Where
- 1 siteHungary
- Study dates
- Nov 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Caucasians subjects presenting multiple Miller Class I. and II. gingival recessions (Multiple Adjacent Recession Type Defects, MARTD) were recruited in the Department of Periodontology in Semmelweis University.
Who may be able to join
- Having thin gingival biotype.
- Clinical diagnosis of multiple gingival recession
- Good general health
Who cannot join
- pregnancy,
- smoking,
- general diseases,
- take any antibiotics, antiinflammatory drugs, systemic steroids, biphosphonates, or any other medicines possibly influencing mucosal wound healing or any other products in the last three months (except contraceptives)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Laser Speckle Contrast Imaging for Assessment of Oral Mucosal Blood Flow Following Periodontal Plastic Surgery: an Exploratory Observational Study
Our overall goal is to characterize the role of the microcirculation in healing oral mucosa after routinely applied surgery intervention in order to facilitate treatment. Using Laser Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation in case of wound healing. After periodontal surgery, by means of the detection of microcirculation as a prognostic and diagnostic factor, the investigators can follow-up the healing procedure and obtain data so as to design e.g. the incision line that takes microvascular anatomy into account, thus result in better wound healing later on.
Read the detailed description
In today's periodontal plastic surgery numerous flap designs with various grafting alternatives (auto-allo- or xeno-grafts) are routinely applied. In order to achieve uneventful primary intention healing and to allow for graft integration resulting in successful clinical outcomes it is important to apply optimized surgical techniques with suitable graft materials to address various clinical demands (e.g. recession coverage, enlargement of keratinized tissues, correction of periimplant soft tissue deficiencies). Graft exposure during soft- and hard tissue augmentation might occur before any chance of graft vascularization due to wound healing disturbances and lack of primary intention healing. The reasons of flap failure could be compromised flap circulation, which can be avoided by proper flap design, tension free flap advancement. The role of flap design on the gingival blood flow was investigated after surgery and found that the simplified papilla preservation flap resulted in faster recovery of the blood flow than the modified Widman flap surgery. In order to minimize trauma on surrounding tissues (i.e. flap) it is recommendable to use the least invasive method for flap preparation, which may also protect the underlining graft tissue and support quick vascularization. These guidelines led to develop a minimal invasive flap design for root coverage surgery, namely supraperiosteal envelope Tunnel technique, which was later modified by Azzi et al. to coronally advance the mucogingival complex in order to cover the inserted graft. Later it was further modified by introducing microsurgical approach. The question still remains to be answered how the Tunnelling technique can influence microcirculation of the healing gingiva and how the underlying graft tissue affects the overlying mucosal flap.
Recently a new non-invasive, two dimensional method, namely the laser speckle contrast analysis (LASCA) has been introduced to evaluate microcirculation of tissue. Clinical pilot studies are suggesting that this technique may be useful tool for assessing the proper circulation during surgical intervention and evaluating wound healing in the skin in human. This new method may let us monitor the entire surgical area real-time before and during the healing period.
- Conditions
- Gingival Recession
- Being tested
- laser speckle contrast imaging of the oral mucosa, wound fluid measurement
- Keywords
- microcirculation, wound healing, tunnel technique, gingival recession, Mucograft, laser speckle contrast analyzer
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser speckle contrast imaging of the oral mucosaDevice
Also called LASCA, Perimed PSI
Non-invasive method to measure tissue blood perfusion applied for oral mucosa
wound fluid measurementDevice
Also called Periotron
Wound fluid at the gingival sulcus was volumetrically measured by Periotron 8000 instrument using filter strip
| Study group | Role | What they receive |
|---|---|---|
| Mucograft | Laser speckle contrast imaging of the oral mucosa and wound fluid measurement before and after root coverage surgery. In this group the roots are covered by a combination of modified coronally advanced flap and xenograft collagen matrix (Mucograft). Receives: Device: laser speckle contrast imaging of the oral mucosa; Device: wound fluid measurement | |
| CTG | Laser speckle contrast imaging of the oral mucosa and wound fluid measurement before and after root coverage surgery. In this group the roots are covered by a combination of modified coronally advanced flap and subepithelial connective tissue graft (CTG), which was harvested from the patient's palate. Receives: Device: laser speckle contrast imaging of the oral mucosa; Device: wound fluid measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative blood flow changes of the oral mucosa
The blood flow changes were measured by Laser Speckle Contrast Analyzer (LASCA) before and after root coverage surgery (modified coronally advanced technique). The scale was an arbitrary unit (0-3000 LSPU) and the relative changes to the pre-operative measurement were calculated. Postoperative follow-up time-points were: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 17, 30, 60, 90, 120, 150, 180 days. The surgery was done with application of two different grafts (Mucograft-xenograft and connective tissue graft-autologous). The differences in postoperative blood flow changes were compared between the two graft-groups.
Measured: 6 months after surgery
Secondary outcomes (1)
Postoperative wound fluid changes of the oral mucosa
The wound fluid changes were measured by Periotron 8000 instrument. Using a filter strip to withdraw the fluid around the wound. The filter strip was then inserted into the Periotron machine to score the volume on the paper. The scores were in a range of 0-200 (arbitrary unit). Postoperative follow-up time-points were: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 17, 30, 60, 90, 120, 150, 180 days. The surgery was done with application of two different grafts (Mucograft-xenograft and connective tissue graft-autologous). The differences in postoperative wound fluid changes were compared between the two graft-groups.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Hungarian Scientific Research Fund
- Responsible party
- Principal investigator, Dr. Vag Janos, Semmelweis University
- Investigators
- Janos Vag, Principal investigator, Semmelweis University, Dept. of Conservative Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540590
- Sponsor's protocol ID
- 1/2013
- Acronym
- LASCAM
- Status last verified
- Sep 2015
- First submitted
- 25 Aug 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Laser Speckle Contrast Imaging for Assessment of Oral Mucosal Blood Flow Following Periodontal Plastic Surgery: an Exploratory Observational Study
- ClinicalTrials.gov ID
- NCT02540590
- Acronym / sponsor ID
- LASCAM / 1/2013
- Conditions
- Gingival Recession
- Keywords
- microcirculation, wound healing, tunnel technique, gingival recession, Mucograft, laser speckle contrast analyzer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Hungarian Scientific Research Fund
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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.
Our overall goal is to characterize the role of the microcirculation in healing oral mucosa after routinely applied surgery intervention in order to facilitate treatment. Using Laser Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation in case of wound healing. After periodontal surgery, by means of the detection of microcirculation as a prognostic and diagnostic factor, the investigators can follow-up the healing procedure and obtain data so as to design e.g. the incision line that takes microvascular anatomy into account, thus result in better wound healing later on.
Detailed description
In today's periodontal plastic surgery numerous flap designs with various grafting alternatives (auto-allo- or xeno-grafts) are routinely applied. In order to achieve uneventful primary intention healing and to allow for graft integration resulting in successful clinical outcomes it is important to apply optimized surgical techniques with suitable graft materials to address various clinical demands (e.g. recession coverage, enlargement of keratinized tissues, correction of periimplant soft tissue deficiencies). Graft exposure during soft- and hard tissue augmentation might occur before any chance of graft vascularization due to wound healing disturbances and lack of primary intention healing. The reasons of flap failure could be compromised flap circulation, which can be avoided by proper flap design, tension free flap advancement. The role of flap design on the gingival blood flow was investigated after surgery and found that the simplified papilla preservation flap resulted in faster recovery of the blood flow than the modified Widman flap surgery. In order to minimize trauma on surrounding tissues (i.e. flap) it is recommendable to use the least invasive method for flap preparation, which may also protect the underlining graft tissue and support quick vascularization. These guidelines led to develop a minimal invasive flap design for root coverage surgery, namely supraperiosteal envelope Tunnel technique, which was later modified by Azzi et al. to coronally advance the mucogingival complex in order to cover the inserted graft. Later it was further modified by introducing microsurgical approach. The question still remains to be answered how the Tunnelling technique can influence microcirculation of the healing gingiva and how the underlying graft tissue affects the overlying mucosal flap.
Recently a new non-invasive, two dimensional method, namely the laser speckle contrast analysis (LASCA) has been introduced to evaluate microcirculation of tissue. Clinical pilot studies are suggesting that this technique may be useful tool for assessing the proper circulation during surgical intervention and evaluating wound healing in the skin in human. This new method may let us monitor the entire surgical area real-time before and during the healing period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucograft | – | Device: laser speckle contrast imaging of the oral mucosa, Device: wound fluid measurementLaser speckle contrast imaging of the oral mucosa and wound fluid measurement before and after root coverage surgery. In this group the roots are covered by a combination of modified coronally advanced flap and xenograft collagen matrix (Mucograft). |
| CTG | – | Device: laser speckle contrast imaging of the oral mucosa, Device: wound fluid measurementLaser speckle contrast imaging of the oral mucosa and wound fluid measurement before and after root coverage surgery. In this group the roots are covered by a combination of modified coronally advanced flap and subepithelial connective tissue graft (CTG), which was harvested from the patient's palate. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Caucasians subjects presenting multiple Miller Class I. and II. gingival recessions (Multiple Adjacent Recession Type Defects, MARTD) were recruited in the Department of Periodontology in Semmelweis University.
Key inclusion criteria (3 listed)
- Having thin gingival biotype.
- Clinical diagnosis of multiple gingival recession
- Good general health
Key exclusion criteria (4 listed)
- pregnancy,
- smoking,
- general diseases,
- take any antibiotics, antiinflammatory drugs, systemic steroids, biphosphonates, or any other medicines possibly influencing mucosal wound healing or any other products in the last three months (except contraceptives)
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 imaging of the oral mucosaAlso: LASCA, Perimed PSINon-invasive method to measure tissue blood perfusion applied for oral mucosa | Device | CTG, Mucograft |
| wound fluid measurementAlso: PeriotronWound fluid at the gingival sulcus was volumetrically measured by Periotron 8000 instrument using filter strip | Device | CTG, Mucograft |
Primary outcome
Postoperative blood flow changes of the oral mucosa
Time frame: 6 months after surgery
The blood flow changes were measured by Laser Speckle Contrast Analyzer (LASCA) before and after root coverage surgery (modified coronally advanced technique). The scale was an arbitrary unit (0-3000 LSPU) and the relative changes to the pre-operative measurement were calculated. Postoperative follow-up time-points were: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 17, 30, 60, 90, 120, 150, 180 days. The surgery was done with application of two different grafts (Mucograft-xenograft and connective tissue graft-autologous). The differences in postoperative blood flow changes were compared between the two graft-groups.
1 secondary outcome
Postoperative wound fluid changes of the oral mucosa
Time frame: 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
Related trials for Gingival Recession
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Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
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Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
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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. This study is not recruiting at the moment.
Janos Vag principal investigator
Semmelweis University, Dept. of Conservative Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Recession, run by Semmelweis University at 1 site in Hungary.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 4 Sep 2015. 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative blood flow changes of the oral mucosa (time frame: 6 months after surgery). 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 4 Sep 2015.