Comparative efficacy of modified versus standard deproteinized bovine bone mineral for compromised socket preservation: a randomized controlled trial

Abstract

Background Socket preservation with deproteinized bovine bone mineral (DBBM) is standard practice following tooth extraction, yet outcomes in compromised sockets with damaged buccal walls due to severe periodontitis remain unpredictable, with excessive fibrous tissue formation limiting bone regeneration. This randomized controlled trial evaluated the histomorphometric efficacy of a novel DBBM (DB1) compared to standard DBBM (DB2) in compromised sockets, with primary focus on new bone formation and tissue composition, supplemented by clinical and radiographic assessments. Materials and methods This randomized, controlled, single-blind clinical trial randomized 34 patients (31 completed per-protocol analysis) requiring single tooth extraction due to severe periodontitis or combined endodontic-periodontal lesions. Participants were randomly allocated to test (DB1, n = 17) or control (DB2, n = 17) groups, with all sites covered by collagen membrane. Bone biopsies were harvested at 16 weeks during implant placement for histomorphometric analysis using digital pathology software. Primary outcome was percentage of newly formed bone. Non-inferiority was assessed at three stringency levels (Delta = -7%, -5%, -3.5%): DB1 was considered non-inferior to DB2 if the lower bound of the 95% confidence interval for the difference (DB1-DB2) exceeded each threshold. Secondary outcomes included residual graft material, bone marrow and fibrous tissue, bone remodeling efficiency, implant stability quotient changes, and radiographic density changes measured by cone-beam computed tomography. Results New bone formation in the test group (17.7 +/- 9.8% vs. 10.8 +/- 9.6%) demonstrated non-inferiority, with the 95% CI lower bound (-0.19%) exceeding all three predefined margins (mean difference + 6.95%, p < 0.001). Bone remodeling efficiency similarly demonstrated non-inferiority (0.23 +/- 0.15 vs. 0.13 +/- 0.14; p < 0.001). The test group showed significantly lower bone marrow and fibrous tissue content (47.4 +/- 17.0% vs. 62.8 +/- 19.8%; p = 0.028) with higher residual graft retention (34.8 +/- 12.2% vs. 26.5 +/- 11.5%; p = 0.059). No significant differences were observed in implant stability or radiographic density changes. Conclusions DB1 demonstrated non-inferiority to DB2 for compromised socket preservation, exhibiting distinct tissue composition patterns with reduced fibrous tissue formation and enhanced volume maintenance capacity.