Dimensional changes of peri-implant tissue following immediate flapless implant placement and provisionalization with or without xenograft in the anterior maxilla: a study protocol for a randomized controlled trial

BACKGROUND: Dental implant therapy requires the preservation of peri-implant tissue in the cosmetic zone. Various surgical procedures have been presented, including ridge preservation, flapless method, and quick provisionalization. The goal of this research was to assess the buccal bone dimensional changes following immediate flapless implant implantation in the front maxilla, with or without xenografting. METHOD AND DESIGN: Thirty patients who meet the inclusion criteria and have maxillary teeth (numbers 14 to 24) are candidates for the immediate implant with immediate provisionalization. Participants will be assigned randomly to one of two groups: (1) an immediate implant with xenograft and (2) an immediate implant without bone grafting. For 3 months, the temporary prosthesis will be installed shortly before the final restoration. Following temporary prosthesis insertion and 6 months after surgery, a CBCT radiograph will be used to examine bone tissue. Soft tissue will be assessed at three points: baseline, 3 months, and 6 months following implant therapy. Patients’ satisfaction, implant failure, prosthesis failure, and complications will be assessed as secondary outcomes after 6 months. DISCUSSION: The outcomes of this randomized clinical research will show if buccal bone augmentation with xenograft reduces vertical bone and gingiva recession. The findings and patient-reported outcomes will aid in the selection of therapy alternatives for implant treatment patients. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20211119053106N1. Registered on 6 December 2021 and Open Science Framework (OSF) on May 20, 2022. Registration DOI 10.17605/OSF.IO/VUGFQ.