Fascia lata allograft versus subepithelial connective tissue graft for peri-implant mucosal augmentation at implant placement: a randomized pilot clinical trial

OBJECTIVES: To compare fascia lata allograft (FLA) and subepithelial connective tissue graft (SCTG) for peri-implant mucosal augmentation performed simultaneously with implant placement. MATERIALS AND METHODS: This prospective, randomized, examiner-blinded pilot clinical trial enrolled 16 patients requiring single-tooth implant placement with a thin peri-implant soft-tissue phenotype. Participants were randomly allocated (1:1) to SCTG or FLA. The primary outcome was peri-implant mucosal thickness (PMT) measured by using a customized stent-guided transmucosal method at standardized buccal reference points. Secondary outcomes included keratinized mucosal width (KMW), postoperative pain (VAS), and modified wound healing index (MWHI). Follow-up was 24 weeks. RESULTS: Both groups demonstrated significant improvements in PMT and KMW over time. Between-group differences were generally non-significant, except localized PMT differences at the intermediate reference level, favoring SCTG at later visits. FLA showed lower postoperative pain at selected time points. Healing outcomes were comparable. CONCLUSION: Both SCTG and FLA were effective for peri-implant mucosal augmentation. FLA may represent a viable alternative that avoids donor-site morbidity. Larger long-term trials are required. CLINICAL RELEVANCE: FLA can be considered a viable alternative for enhancing peri-implant mucosal thickness around simultaneously placed dental implants. TRIAL REGISTRATION: ClinicalTrials.gov NCT04679922, registered on December 22, 2020, and retrospectively registered.