When a dental extraction is performed, sequential cascade of events happens that lead to a modeling and remodeling of the area. This phenomenon leads to bone resorption and consequential volume loss atrophy. In literature several biomaterials (Autogenous, alloplastic, allografts and xenografts) were tested as alveolar fillers with the aim of controlling this physiologic event. Socket preservation is today a very widely spread dental technic to preserve the alveolar dimensions, that uses a wide range of biomaterials. Alloplastic materials have a fair evidence to work in several regenerative procedures in the oral and maxillofacial region. This pilot trial aims to characterize Histologic bone healing pattern in a human socket preservation model of 2/3 biphasic calcium sulfate cement matrix's and Hydroxyapatite (HA granules). Alterations in Volumetric alveolar socket changes in a socket preservation clinical model will also be studied.
Aim : To evaluate histologic performance and volumetric outcome of a bone substitute used in dentistry for guided bone regeneration procedures. Model : Human Socket preservation surgery with a control group of spontaneous alveolar healing. Inclusion criteria includes a class 2 or 3 (loss of at least 1/3 of the buccal bone of the alveolar socket) post-extraction sockets. Clinical Experimental Methodology : Atraumatic extraction of the hopeless tooth without flap retraction, after socket mechanical debridement , fill with 2/3 biphasic calcium sulfate cement matrix's with Hydroxyapatite (HA granules) and covered with a resorbable membrane. 3 Month after a CBCT is performed for implant planning. At implant placement a 2 mm trephine will be used for core extraction. Measurements (Stl File) on the day of surgery (Baseline T0) and at implant placement (3 month after tooth extraction) (T1) and after delivery final crown (T2). Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant will be used at T0, T1 and T2. Histologic measure comprise percentage of vital bone formation, fibrous/connective tissue, and material remnant, in a socket preservation model To Measure Volumetric changes reverse engineering software (Geomagic Control X, 3D Systems) will be used. Other evaluation parameters involve radiographic Cone Beam Computer Tomography evaluation, primary stability, implant survival and implant success rate Clinical Control Methodology : Atraumatic extraction of the hopeless tooth without flap retraction, after socket mechanical debridement Measurements (Stl File) on the day of surgery (Baseline T0) and at 3 month after tooth extraction) (T1) Discrepancy (Trueness) Between Standard Tessellation Language Files in Teeth Adjacent to Implant will be used at T0 and T1
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Pre-op CBCT scanner for evaluating bone conditions around hopeless tooth. If 1/3 of the buccal plate is missing, considered a class 2 alveolar socket. Extraction of tooth and place 2/3 biphasic calcium sulfate cement matrix's with Hydroxyapatite (HA granules) , condensed , and covered with a resorbable membrane suture to the adjacent tissue. At implant placement ,take bone for histological preparation and histomorphometric analysis of the healing pattern. At T0, T1 and T2 measure adjacent teeth periodontal status , Probing Depth , bleeding on probing. Volumetric measurements, will use fixed landmarks (ex. adjacent teeth) to calibrate the STL measurements. Calculate the difference between pre-extraction socket and the post treatment with the alloplastic material. Primary and secondary stability will be measured by ISQ units with a RFA machine, that will include the machine to measure and the magnetic tip to be screwed in the implant platform.
Pre-op CBCT scanner for evaluating bone conditions around hopeless tooth, at extraction day, no flap opening , atraumatic extraction, no biomaterial filler, At T0, T2 measure adjacent teeth periodontal status , Probing Depth , bleeding on probing. Volumetric measurements will include an intramural scanner from all the stages , we will use fixed landmarks (ex. adjacent teeth) to calibrate the STL measurements. Calculate the difference between pre-extraction socket and the post treatment with the alloplastic material.
Histologic Examination Histomorphometric Analysis
Histologic measure, percentage of Vital Bone formation, Fibrous/connective tissue, and material remnant present in the sample.
Time frame: 3 month after tooth extraction
Volumetric Changes Clinical
Measure Linear changes reverse engineering software (Geomagic Control X, 3D Systems) in mm.
Time frame: at pre-extraction and at final crown insertion up to 1 year
Radiographic CBCT - Bone evaluation
Measure Linear changes in bone from T0 baseline to Implant Placement T1 in mm
Time frame: at pre-extraction and at final crown insertion up to 1 year
Primary and Secondary stability
Measure the Resonance Frequency Analysis at implants placed in regenerated bone
Time frame: at implant placement and at dental crown insertion up to 1 year
Incidence of Implant Success rate
Measure implant status peri-implant parameters , bleeding on probing in percentage of sites
Time frame: at final treatment (crown insertion) up to 1 year
Implant probing depth
Measure the attachment loss in mm
Time frame: At implant insertion and At final treatment (crown insertion) up to 1 year
Implant marginal bone loss.
Measure bone position regarding Implant Platform
Time frame: at implant placement and at final crown insertion (up to 1 year)
Incidence of Survival rate
if the implant is osseointegrated
Time frame: at dental crown placement (final treatment) up to 1 year
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