The Effect of Different Hemostatic Agents on Hemorrhage Control, Pain and Quality of Life After Endodontic Microsurgery: a Randomized Clinical Trial

Eligibility criteria Consecutive informed and consenting healthy subjects (ASA 1-2) of both genders with no medical history of systemic disease and presenting a diagnosis of symptomatic or asymptomatic apical periodontitis in correspondence of endodontically treated teeth with medium (2-5 mm3) and large (≥5 mm3) periapical lesions were enrolled. The diagnosis was performed clinically and radiographically through periapical radiographs and small field of view (FOV) Cone-Beam Computed Tomography (CBCT). The lesions volume and diameters were evaluated using the dedicated software Mimics 24.0 (Materialise, Belgium). Only periapical defects with one or two residual cortical walls were considered, while bone cavity designs with no cortical walls were excluded. The clinical indications for retrograde endodontic retreatment were reported for all cases: the teeth presented inadequate root canal treatment with periapical radiolucency and impossible access through orthograde retreatment due to the presence of prosthetic restorations, posts, canal blocks and ledges. Moreover, the teeth presented an adequate coronal seal and absence of pathological periodontal records.

The subjects affected by diabetes mellitus, hypertension and hepatic or renal diseases were excluded from the study. Similarly, exclusion criteria included bleeding disorders, pregnancy and antiplatelet or anticoagulant therapy. The teeth that were considered unrestorable and the elements affected by fractures or extensive periodontal defects were also dismissed. A written consensus reporting information about the surgical procedure and the clinical and radiographical follow-up was supplied.

Sample size calculation The sample size calculation was estimated basing on clinical outcomes. In particular, basing on the VAS score reduction as primary endpoint, a study power of 80%, with a significance level of 5%, and a standard deviation of 6.24 was calculated and 10 subjects per set group were needed.

Randomization and allocation The patients were blind about the randomization that was performed by assigning a code. Double blinding was not possible due to the use of different hemostatic agents during the surgical procedure.

Treatment procedure The procedure was completed by one single experienced surgeon in a sterile environment using an operating microscope (OPMI Pro Ergo, Carl Zeiss, Germany). After the administration of local anesthesia with articaine 1:100,000 (Septodont, France) and 10 minutes later lidocaine 2% with epinephrine 1:50,000 (Dentsply Sirona, USA), a full thickness mucoperiosteal flap was elevated. The debridement of the periradicular lesion was obtained using surgical curettes (Hu-Friedy) and the bone crypt was completed with a dedicated bur (#557 SL Lindemann; Brasseler USA, Savannah, GA). After curettage, the surgeon and two independent assistants evaluated the hemorrhage degree and the visibility of the surgical field. Afterwards, in group 1 (n=15) the surgical glue (IfaBond, Dipromed, Italy) was applied for the hemorrhage control in the bone crypt with a needle 23G, while in group 2 (n=19) the ferric sulfate 15.5% (Astringedent) was positioned in the surgical site through compression with a cotton pellet. The qualitative analysis of bleeding score and the visibility of the surgical site after the use of the hemostatic agent was evaluated.