Post-operative Blood Flow Measurements of the Oral Mucosa

Completed

• Conditions: Gingival Recession
• Interventions: Device: laser speckle contrast imaging of the oral mucosa; Device: wound fluid measurement

• Registration Number: NCT02540590
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2015-08-25
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-03
• Last Update Submitted: 2015-09-03
• Study First Posted: 2015-09-04
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mucograft	wound fluid measurement	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).
CTG	laser speckle contrast imaging of the oral mucosa	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.
Mucograft	laser speckle contrast imaging of the oral mucosa	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).
CTG	wound fluid measurement	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.

Primary Outcome Measures

Name	Time	Method
Postoperative blood flow changes of the oral mucosa	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative wound fluid changes of the oral mucosa	6 months after surgery	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.

Trial Locations

Locations (1)

Janos Vag; 🇭🇺 Budapest, Hungary