Mucogingival DefectNCT02975024
Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures
An observational study of Mucogingival Defect, run by Semmelweis University at 1 site in Hungary.
Trial summary
Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes during wound healing in human subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucogingival Defect
- What is being tested?
- laser speckle contrast imaging of the oral mucosa, wound fluid measurement and quantitative determination of VEGF
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 8 participants
- Where
- 1 siteHungary
- Study dates
- Nov 2016to Dec 2017
- 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 18 to 45 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
- clinical diagnosis of inadequate width of keratinized gingiva at the mandibular front region
Who cannot join
- pregnancy
- heavy smoking
- general diseases
- taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, anti-inflammatory drugs)
- taking any other medications in the last three months (except contraceptives)
Trial locations and contacts
1 site in 1 country.
About this study
Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes during wound healing in human subjects.
Read the detailed description
Vestibuloplasty is the common name of those procedures designed to widen the zone of attached gingiva. The apically repositioned split thickness flap with a xenogeneic collagen matrix or with a combination of strip gingival graft and a xenogeneic collagen matrix are frequently used surgical techniques, however no data are available, how these graft tissues affect the microcirculation of the healing gingiva.
LSCI is a non-invasive, two dimensional method to evaluate microcirculation of different tissues. This new method let us monitor the entire surgical area real-time during the healing period.
The aim of the present study is to define blood flow patterns, which might characterize the wound healing of such surgical procedures during the first 6 months of healing in order to facilitate treatment.
- Conditions
- Mucogingival Defect
- Being tested
- laser speckle contrast imaging of the oral mucosa, wound fluid measurement, quantitative determination of VEGF
- Keywords
- mandibular vestibuloplasty, wound healing, microcirculation, Laser Speckle Contrast Imager, Mucograft, strip gingival graft
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 LSCI Perimed PSI
Non-invasive method to measure tissue blood perfusion applied for oral mucosa
wound fluid measurementDevice
Also called Periotron 8010
Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.
quantitative determination of VEGFDevice
Also called Human VEGF Quantikine ELISA Kit
For the quantitative determination of VEGF in the fourth day wound fluid sample the Human VEGF Quantikine ELISA Kit will be used.
| Study group | Role | What they receive |
|---|---|---|
| Mucograft | Laser speckle contrast imaging of the oral mucosa and wound fluid measurement and quantitative determination of VEGF after mandibular vestibuloplasty. Individuals of this pre-defined group are candidates of vestibuloplasty, where the keratinized gingiva will be enlarged by a combination of apically repositioned split thickness flap with a xenogeneic collagen matrix (Mucograft). Receives: Device: laser speckle contrast imaging of the oral mucosa; Device: wound fluid measurement; Device: quantitative determination of VEGF | |
| strip gingival graft + Mucograft | Laser speckle contrast imaging of the oral mucosa and wound fluid measurement and quantitative determination of VEGF after mandibular vestibuloplasty. Individuals of this pre-defined group are candidates of vestibuloplasty, where the keratinized gingiva will be enlarged by a combination of apically repositioned split thickness flap with a strip gingival graft and a xenogeneic collagen matrix (Mucograft). The strip gingival graft is harvested from the patient's palate. Receives: Device: laser speckle contrast imaging of the oral mucosa; Device: wound fluid measurement; Device: quantitative determination of VEGF |
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
Blood flow changes are measured by Laser Speckle Contrast Imager (LSCI) after mandibular vestibuloplasty. The scale is an arbitrary unit (0-3000 LSPU) and the relative changes to the surgically unaffected surrounding mucosa measurements are calculated. Postoperative follow-up time-points are: 1, 2, 3, 4, 5, 6, 7, 9, 11, 14, 21, 28 days, and 2, 3, 4, 5, 6 months. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative blood flow changes are compared between the two surgical techniques.
Measured: 6 months after surgery
Secondary outcomes (3)
Wound fluid volume measurement
Wound fluid sample is collected using a filter strip to withdraw the fluid around the wound. The filter strip is then inserted into Periotron 8010 instrument to score the volume on the paper. Scores are measured in an arbitrary unit. Postoperative follow-up time-points are: 1, 2, 3, 4, 5, 6, 7, 9, 11, 14 days. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative wound fluid changes are compared between the two surgical techniques.
Measured: 14 days after surgery
Evaluation of the periodontal parameters at teeth at the surgical site: a composite outcome measure consisting of multiple measures.
Periodontal parameters are evaluated using a periodontal probe and will be expressed in mm. The following will be assessed at each tooth at the surgical site: probing depth, depth and width of recession, papilla height, and width and thickness of the keratinized gingiva. Surgical area is also measured apico-coronally and mesio-distally, during the whole follow-up period.
Measured: Pre- and six month postoperative
Quantitative determination of Vascular Endothelial Growth Factor (VEGF) of the wound fluid
Wound fluid sample for VEGF is collected at the fourth postoperative day. For the quantitative determination of VEGF in samples the Human VEGF Quantikine ELISA Kit will be used. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative wound fluid level of VEGF (expressed in conc pg/mL) are compared between the two surgical techniques.
Measured: 4 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucogingival DefectStudies 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
- NCT02975024
- Sponsor's protocol ID
- 3/2013
- Status last verified
- Apr 2018
- First submitted
- 16 Nov 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures
- ClinicalTrials.gov ID
- NCT02975024
- Acronym / sponsor ID
- 3/2013
- Conditions
- Mucogingival Defect
- Keywords
- mandibular vestibuloplasty, wound healing, microcirculation, Laser Speckle Contrast Imager, Mucograft, strip gingival graft
- 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 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Nov 2016 (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.
Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes during wound healing in human subjects.
Detailed description
Vestibuloplasty is the common name of those procedures designed to widen the zone of attached gingiva. The apically repositioned split thickness flap with a xenogeneic collagen matrix or with a combination of strip gingival graft and a xenogeneic collagen matrix are frequently used surgical techniques, however no data are available, how these graft tissues affect the microcirculation of the healing gingiva.
LSCI is a non-invasive, two dimensional method to evaluate microcirculation of different tissues. This new method let us monitor the entire surgical area real-time during the healing period.
The aim of the present study is to define blood flow patterns, which might characterize the wound healing of such surgical procedures during the first 6 months of healing in order to facilitate treatment.
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 measurement, Device: quantitative determination of VEGFLaser speckle contrast imaging of the oral mucosa and wound fluid measurement and quantitative determination of VEGF after mandibular vestibuloplasty. Individuals of this pre-defined group are candidates of vestibuloplasty, where the keratinized gingiva will be enlarged by a combination of apically repositioned split thickness flap with a xenogeneic collagen matrix (Mucograft). |
| strip gingival graft + Mucograft | – | Device: laser speckle contrast imaging of the oral mucosa, Device: wound fluid measurement, Device: quantitative determination of VEGFLaser speckle contrast imaging of the oral mucosa and wound fluid measurement and quantitative determination of VEGF after mandibular vestibuloplasty. Individuals of this pre-defined group are candidates of vestibuloplasty, where the keratinized gingiva will be enlarged by a combination of apically repositioned split thickness flap with a strip gingival graft and a xenogeneic collagen matrix (Mucograft). The strip gingival graft is harvested from the patient's palate. |
Who may qualify
- Ages
- 18 to 45 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 (1 listed)
- clinical diagnosis of inadequate width of keratinized gingiva at the mandibular front region
Key exclusion criteria (5 listed)
- pregnancy
- heavy smoking
- general diseases
- taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, anti-inflammatory drugs)
- taking any other medications 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: LSCI Perimed PSINon-invasive method to measure tissue blood perfusion applied for oral mucosa | Device | Mucograft, strip gingival graft + Mucograft |
| wound fluid measurementAlso: Periotron 8010Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument. | Device | Mucograft, strip gingival graft + Mucograft |
| quantitative determination of VEGFAlso: Human VEGF Quantikine ELISA KitFor the quantitative determination of VEGF in the fourth day wound fluid sample the Human VEGF Quantikine ELISA Kit will be used. | Device | Mucograft, strip gingival graft + Mucograft |
Primary outcome
Postoperative blood flow changes of the oral mucosa
Time frame: 6 months after surgery
Blood flow changes are measured by Laser Speckle Contrast Imager (LSCI) after mandibular vestibuloplasty. The scale is an arbitrary unit (0-3000 LSPU) and the relative changes to the surgically unaffected surrounding mucosa measurements are calculated. Postoperative follow-up time-points are: 1, 2, 3, 4, 5, 6, 7, 9, 11, 14, 21, 28 days, and 2, 3, 4, 5, 6 months. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative blood flow changes are compared between the two surgical techniques.
3 secondary outcomes
Wound fluid volume measurement
Time frame: 14 days after surgery
Evaluation of the periodontal parameters at teeth at the surgical site: a composite outcome measure consisting of multiple measures.
Time frame: Pre- and six month postoperative
Quantitative determination of Vascular Endothelial Growth Factor (VEGF) of the wound fluid
Time frame: 4 days 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 18 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Mucogingival Defect
Active, not recruiting
A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.
Gingival Recession, Lack of Keratinized Gingiva
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 Mucogingival Defect, 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 1 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: finished, as of the sponsor's last update on 18 Apr 2018. 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 18 Apr 2018.