Comparative Evaluation of the Effectiveness of Demineralized Freeze-Dried Bone Allografts With Titanium Platelet-Rich Fibrin and Autologous Dentin Graft With Titanium Platelet-Rich Fibrin for Alveolar Socket Preservation: Protocol for a Randomized Controlled Trial.

backgroundPostextraction ridge resorption compromises the aesthetics and function of the subsequent implant therapy or prosthetic rehabilitation. Several techniques are employed to reduce ridge resorption, ranging from basic socket fillers such as blood clot preservation to more advanced techniques using barrier membranes and bone grafts such as autografts, allografts, xenografts, and synthetic materials.

objectiveThe aim of this study is to evaluate and compare the effectiveness of alveolar socket preservation by using demineralized freeze-dried bone allograft (DFDBA) with titanium platelet-rich fibrin (T-PRF) and autologous dentin graft (ADG) with T-PRF. This assessment will be performed through comprehensive clinical, radiographic, and histomorphometric analyses. The primary objective of this study is to histologically evaluate the new bone formation in the extraction sockets preserved using either DFDBA with T-PRF or ADG with T-PRF. The secondary objective is to evaluate the dimensional changes, including ridge width and height at these healing points, as measured by clinical and radiographic methods. We will evaluate and compare the clinical, radiographic, and histomorphometric outcomes of using DFDBA with T-PRF versus ADG with T-PRF for maintaining socket integrity after tooth extraction. We will also ascertain which grafting technique facilitates the production of new bone during the healing phase and preserves alveolar ridge dimensions.

methodsThis randomized controlled trial will involve 16 patients aged 22-60 years requiring tooth extractions and subsequent implant placement. Participants will be randomly assigned to one of the 2 groups: (1) socket preservation using DFDBA in combination with T-PRF or (2) socket preservation using ADG with T-PRF. At baseline, all the clinical variables will be assessed using UNC-15 probe and cone beam computed tomography radiographs. Extraction will be done atraumatically with minimal flap reflection by using periotomes. Postextraction sockets will be preserved using DFDBA+T-PRF or ADG+T-PRF. At 4 months, clinical and radiographic evaluations will be done, and the implant will be placed using a 2-stage protocol. Histomorphometric analysis will be performed after receiving bone samples during implant placement. At 3 months after implant placement, the second-stage surgery will be done.

resultsParticipant enrollment commenced in March 2024, and the study is scheduled to conclude postassessments and analyses by the end of 2025. The results of this study are anticipated to be accessible in late 2025. This study is not funded, and the results are expected to be published by 2026.

conclusionsThis study represents valuable insights into the clinical effectiveness of 2 biologically driven socket preservation techniques. We hypothesize that the use of ADG combined with T-PRF will show similar or more effective outcomes in alveolar socket preservation demonstrated by enhanced bone formation and better maintenance of socket dimensions compared to DFDBA combined with T-PRF without increased morbidity.

trial registrationClinical Trials Registry - India CTRI/2024/05/068192; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTI1NzIz&Enc=&userName=. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/70649.