Localized Alveolar Ridge Reconstruction and Soft Tissue Augmentation Using a Triple Graft from the Maxillary Tuberosity versus Xenograft with Connective Tissue Simultaneous with Immediate Implant Placement: A Randomized Controlled Clinical Study

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Abstract

Objectives: To compare the clinical efficacy of a triple graft harvested from the maxillary tuberosity versus a xenograft bone combined with a connective tissue graft for buccal bone reconstruction and soft tissue augmentation around immediate dental implants in the anterior maxilla. Materials and Methods: The sample size for this randomized controlled trial was determined based on the primary outcome of buccal marginal bone thickness above the implant platform at 12 months, informed by previously published data. Using a two‑sided alpha level of 0.05, a power of 80% (β = 0.20), and parameters derived from the reference study (anticipated mean difference and standard deviation), the minimum required sample size was 7 patients per group; this was increased to 12 patients per group (total n = 24) to account for potential drop‑outs, in line with CONSORT recommendations. Twenty‑four patients were enrolled in this prospective, single‑center randomized controlled trial conducted at the Department of Periodontology, Faculty of Dentistry, Ain Shams University, Cairo, Egypt. Randomization employed a computer‑generated sequence (block size 4) to ensure balanced allocation, with allocation concealment achieved using sequentially numbered, sealed opaque envelopes prepared independently and held by the study coordinator. Blinding of the surgeon and patients was not feasible due to the nature of the interventions; however, outcome assessors (radiographic and clinical) and the biostatistician were blinded to group assignment. Patients were allocated to either a triple graft group (TGG), receiving a cortico‑cancellous bone block with a connective tissue component harvested from the maxillary tuberosity, or a xenograft + connective tissue graft group (XGG), receiving deproteinized bovine bone mineral with a free connective tissue graft from the tuberosity. In both groups, implants were placed immediately into Type II extraction sockets in the anterior maxilla, with simultaneous buccal defect reconstruction and delivery of an immediate provisional restoration. Results: At 12 months, buccal marginal bone thickness above the implant platform was significantly greater in the XGG (1.18 ± 0.21 mm) than in the TGG (0.82 ± 0.22 mm; p = 0.0008), indicating a clinically meaningful advantage for the xenograft protocol. The XGG also showed significantly greater buccal bone gain at all measured levels (p = 0.005). Vertical soft tissue loss at mesial, mid‑facial, and distal sites, as well as horizontal soft tissue width reduction, were significantly lower in the XGG compared with the TGG. Pink Esthetic Score values were high in both groups, with no significant differences in papilla levels, but the XGG demonstrated superior soft tissue contour and alveolar process scores. Soft tissue color and texture differences were more frequent in the XGG. Patient‑reported outcomes favored the XGG, with significantly higher satisfaction scores for pain, edema, operative duration, wound healing, and overall satisfaction. Conclusions: Within the limitations of this randomized controlled trial, both autogenous triple grafts and xenograft combined with connective tissue grafting were effective for reconstructing buccal bone defects and augmenting peri‑implant soft tissues in the anterior maxilla with immediate implant placement. However, the xenograft + CTG protocol resulted in significantly greater buccal marginal bone thickness above the implant platform, superior buccal bone gain, better preservation of vertical and horizontal soft tissue dimensions, and higher patient satisfaction at 12 months. Xenograft‑based approaches thus represent a predictable, minimally invasive alternative to autogenous tuberosity grafts for the management of Type II extraction sockets in the esthetic zone. Clinical Trial Registry Date: 12/11/2022 The trial was registered at ClinicalTrials.gov under the number NCT05670067 (Retrospectively registered) Clinical Relevance: For immediate implant placement in type II extraction sockets, xenograft combined with connective tissue grafting provides a predictable, minimally invasive alternative to autogenous grafts, optimizing buccal bone and soft tissue profiles in the anterior esthetic zone and reducing donor site morbidity

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