L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation

Brief SummaryCopy and paste the text below into the Brief Summary text box:The purpose of this randomized controlled clinical trial is to evaluate and compare the clinical, radiographic, and histological outcomes of horizontal ridge augmentation in single edentulous sites in the esthetic zone using a Leukocyte- and Platelet-Rich Fibrin (L-PRF) Block versus a composite graft of autogenous bone and deproteinized bovine bone mineral (DBBM). Following tooth loss, the alveolar ridge undergoes physiological bone resorption, particularly at the thin facial bone wall in the anterior maxilla. Adequate bone volume is required to allow dental implant placement in an ideal prosthetically driven position and to support long-term peri-implant soft tissue stability. Guided bone regeneration (GBR) using a 1:1 composite graft of autogenous bone and DBBM covered by a collagen membrane is considered an established standard technique. However, harvesting autogenous bone requires a secondary surgical donor site, which increases surgical time, patient discomfort, and surgical morbidity. The L-PRF Block combines DBBM particles with patient-derived blood concentrates rich in fibrin and growth factors, eliminating the need for autogenous bone harvesting. In this single-blind, non-inferiority clinical trial, 70 adult patients requiring horizontal ridge augmentation in the esthetic zone before implant placement will be randomly assigned (1:1 ratio) to receive either:Test Group: Horizontal ridge augmentation using an L-PRF Block (DBBM + L-PRF membranes + liquid fibrinogen) covered with a resorbable collagen membrane. Control Group: Horizontal ridge augmentation using a composite graft (1:1 ratio of autogenous bone harvested from the mandibular symphysis and DBBM) covered with a resorbable collagen membrane. Patients will undergo 3D Cone Beam Computed Tomography (CBCT) imaging before surgery ($T\_0$), immediately postoperatively ($T\_1$), and 6 months post-augmentation ($T\_2$). At 6 months ($T\_2$), bone core biopsies will be harvested during implant placement for histological and histomorphometric analysis. Primary implant stability (ISQ) will be recorded at implant placement ($T\_2$), and secondary implant stability (ISQ) will be measured at abutment connection ($T\_3$). Patient-reported outcomes (pain and satisfaction with esthetics/function) and buccal bone plate thickness will be evaluated 6 months after final prosthetic restoration ($T\_4$). The trial aims to test whether the L-PRF Block is non-inferior to the conventional autogenous/DBBM composite graft.

Inclusion Criteria: * Age \>= 18 years at the time of screening. * Presence of a single edentulous tooth gap in the maxillary or mandibular esthetic zone (incisors, canines, or premolars). * Presence of horizontal alveolar ridge deficiency (residual bone width \< 5 mm) requiring staged guided bone regeneration (GBR) prior to dental implant placement. * Adequate vertical bone height for future implant placement (\>= 10 mm above anatomical vital structures). * Intact adjacent natural teeth with stable periodontal health. * Good oral hygiene (Full-Mouth Plaque Index \ 10 cigarettes/day) or active substance abuse. * Untreated active periodontal disease or active infection/periapical pathology at the surgical site or adjacent teeth. * Anatomical constraints or pathological lesions at the mandibular symphysis preventing autogenous bone harvest. * Hematological disorders, severe anemia, or coagulation disorders contraindicating venous blood draw for PRF preparation or surgical procedures. * Pregnant or lactating females. * Known allergy to bovine-derived collagen, bovine bone mineral, or surgical materials used in the study. * Participation in another clinical trial within the past 30 days.