Healing of intrabony defects using a novel human recombinant amelogenin: a preclinical study

Objective: To histologically evaluate the effects of a novel hu-man recombinant amelogenin (rAmelX) on periodontalwound healing/regeneration in intrabonydefects. Method and mater-ials: I ntrabony defects were surgically created in the mandible of three minipigs. Twelve defects were randomly treated with either rAmelX and carrier (test group) or with the carrier on ly (control group). At 3 months following reconstructive surgery, the animals were euthanized, and the tissues histologically pro-cessed. Thereafter, descriptive histology, histometry, and statis-tical analyses were performed. Results: Postoperative clinical healingwas uneventful. Atthe defect level, no adverse reactions (eg, suppuration, abscess formation, unusual inflammatory re- action) were observed with a good biocompatibility of the tested products. The test group yielded higher values for new cemen-tum formation (4.81 +/- 1.17 mm) compared to the control group (4.39 +/- 1.71 m m) without reachi ng statistical significance (P=.937). Moreover, regrowth of new bone was greater in the test com-pared to the control group (3.51 mm and 2.97 mm, respectively, P = .309). Conclusions: The present results provided for the first-time histologic evidence for periodontal regeneration following the use of rAmelX in intrabony defects, thus pointing to the po-tential of this novel recombinant amelogenin asa possible alter-native to regenerative materials from animal origins. (Quintessence Int2023;54:622-628; doi:10.3290/j.gi.b4007601)