Methods: 7 patients with severe periodontitis and found eligible for periodontal surgery were invited to participate in this pilot trial. The trial was conducted in India after registering in the Indian clinical registry (REF/2012/05/003545). The trial with the approval of the institutional ethical committee (Institutional Review Board IRB) is a single-centered, intra-individual, split-mouth, placebo-controlled, randomized prospective longitudinal phase IV clinical trial with blind observer. The trial will be continued as a main trial by completing a total of 15 participants.
On the test site FS (TISSEEL™, Baxter) was applied for tissue approximation after periodontal flap surgery (n=7) and on the control site sutures were used (n=7). Test and control procedures were performed with an interval of 8 to 10 days. IL 1β and IL 8 were quantified from the collected gingival crevicular fluid by commercially available quantitative sandwich enzyme- linked immunoassay kits (Quantikine, R&D Systems, Minneapolis, MN.)
Results: Paired t test was used to find any difference between the test and control cytokine levels. The level of statistical significance was set at α = 0.05. IL1 β concentration of FS treated sites (318.86±167.276pg/µL) were found significantly lower when compared to control sites (593.71±290.764pg/µL); while IL8 did not show any difference (T3326.29±1995.276pg/µL Vs C6527.29±2285.85pg/µL).
Conclusions: The trial showed that there was less inflammation following use of FS. Within limitation, taking less inflammation as a surrogate, it can be stated that use of fibrin sealant for periodontal flap closure results in early wound healing, an important requisite for predictable surgical outcomes.