Treatment of supraosseous defects (SD) may be challenging due to their limited regenerative potential. When located in aesthetic areas, treatment may result in a gingival recession increase with consequent patients' concerns in terms of aesthetic or tooth sensibility. In the present study, a minimally-invasive surgical procedure (namely, the Single Flap Approach, SFA) will be combined with the application of a viscoelastic gel containing polynucleotides and hyaluronic acid that was reported to positively modulate periodontal wound healing. The outcomes, evaluated 6 months after treatment, will be compared to those obtained with SFA alone. The evaluated outcomes will be either clinical (evaluation of clinical parameters such as gingival recession, residual probing depth, clinical attachment gain) or related to patient's perception (such as evaluation of the aesthetic or tooth sensibility).
age≥ 18 years;
diagnosis of Stage III or IV periodontitis22;
good physical status (ASA1 and ASA2 according to Physical Status Classification System);
systemic and local conditions compatible with periodontal surgical procedures;
poorly controlled diabetes (HbA1C ≥ 7%);
history of radiation therapy in the head and neck area;
history of chemotherapy;
systemic disease or conditions with a documented effect on bone metabolism and/or periodontal status/healing;
Parallel
viscoelastic gel containing polynucleotides and hyaluronic acid
DeviceDefects randomized to "test treatment" will receive a viscoelastic gel containing polynucleotides and hyaluronic acid (PN-HA gel) immediately at the completion of intra-surgical instrumentation. PN-HA gel will be also applied on the surgical wound at the completion of the suturing phase.
No intervention
Other interventionDefects randomized to "control group" will be accessed with the SFA and no PN-HA gel will be applied.
Interproximal gingival recession (iREC)
the primary outcome of the study will be iREC change
Prevalence of closed, non bleeding pockets
closed pocket (i.e., residual 6-month probing depth (PD)≤ 4mm)
Quality of early wound closure
The quality of early wound closure will be evaluated using the "early healing index" (EHI), as proposed by Wachtel et al. in 2003. EHI is based on the following scale: (EHI=1) complete flap closure, no fibrin line in the interproximal area; (EHI=2) complete flap closure, fine fibrin line in the interproximal area; (EHI=3) complete flap closure, fibrin clot in the interproximal area; (EHI=4) incomplete flap closure, partial necrosis of the interproximal tissue; and (EHI=5) incomplete flap closure, complete necrosis of the interproximal tissue.
Clinical Attachment Level (CAL) Gain
6-month CAL gain will be calculated by subtracting the 6-month CAL value from the baseline CAL
Change in buccal gingival recession (bREC);
bREC change will be calculated by subtracting the 6-month bREC value from the baseline bREC value
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