Clinical trial NCT02540590: Post-operative Blood Flow Measurements of the Oral Mucosa
Official title: Evaluation of Laser Speckle Contrast Imaging for Assessment of Oral Mucosal Blood Flow Following Periodontal Plastic Surgery: an Exploratory Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gingival Recession
Keywords: microcirculation
wound healing
tunnel technique
gingival recession
Mucograft
laser speckle contrast analyzer
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: Hungarian Scientific Research Fund
First posted: 2015-09-04
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Having thin gingival biotype.
* Clinical diagnosis of multiple gingival recession
* Good general health

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Postoperative blood flow changes of the oral mucosa
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Postoperative wound fluid changes of the oral mucosa
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Janos Vag
Study officials:
affiliation: Semmelweis University, Dept. of Conservative Dentistry
name: Janos Vag
role: PRINCIPAL_INVESTIGATOR
References: