"Osseodensification Efficacy on Molar Septum Expansion in Immediate Molar Implant Placement: A Randomized Controlled Clinical Trial

The proposed study consists of two arms: 1- Clinical arm, 2- Ex-Vivo arm

The clinical arm:

80 patients with hopeless teeth requiring extraction in the molar region and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, Ain shams university according to the inclusion criteria. They will be randomly allocated into two equal groups. 40 patients in the osseodensification group and 40 patients in the conventional drilling group. Each group will be further subdivided into two groups with and without jumping gap graftingPerioperative and postoperative CBCT will be ordered, and perioperative and postoperative impressions will be made and scanned for each patient to prepare a virtual 3D model before extraction and after extraction and implant placement. Molar septum dimensions will be compared before and after implant placement in addition to evaluation of vertical and horizontal alveolar bone changes and changes in bone density after placement of immediate implant in extraction socket, also a volumetric analysis will be made to assess the changes in the buccal ridge contour before and after implant placement with and without grafting of the jumping gap. Clinical outcomes will be assessed including (success and survival of implants, insertion torque, ISQ values, Probing depth, modified pink esthetic score, KTW, and patient satisfaction) all the outcomes will be assessed as baseline before the implant placement and will be followed up at 0,6 and 12 months after implant placementThe Ex-Vivo arm: study will be conducted in an ex vivo animal model using porcine bones. The animals won't be used exclusively for this study and the bones will be collected as if it was disposable as waste material, so ethical approval will not be necessary. Both tibias of a single skeletally mature porcine will be collected on the day of the slaughter. To prepare the samples, approximately 15 mm of the articular surface and subchondral bone will be removed by transversely sectioning the bones, thereby exposing the medullary portion. Three canals for thermocouples at three different depths (2 mm: T1-cortical bone, 7.5 mm: T2-cancellous bone, and 10.5 mm: T3- deep cancellous bone) from the crest of the pig bone will be drilled using 1.5 mm twist drill perpendicularly to each implant site preparation and using intermittent cutting to a distance approximately 1 mm from the planned osteotomy site.The thermocouples will be secured to the bone blocks at a distance of approximately 1 mm from the future osteotomy and insulated using sticky wax at the canal opening This study will be performed on 12 samples removed from the tibias, divided into two groups according to the drilling technique: a control group of the conventional technique (CT) (n=6), and a test group of osseodensification (OD) (n=6). The evaluation of bone microstructure using Micro-CT will follow the guidelines proposed by Bouxsein et al. (2010), which includes the use of terminologies, procedures, images, and reporting of the results. The thermocouples will be connected to a digital thermometer that allows continuous temperature reading, and temperature changes (baseline and final temperature readings) during the osteotomy preparation will be recorded for statistical analysis