Biomaterial Clinical Performance in a Socket Preservation Model

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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

Official Title
-----------------
Comparative Clinical Performance of Biphasic Calcium Sulfate Cement Matrix With Hydroxyapatite Granules in a Socket Preservation Model: a Pilot Clinical Trial Parallel Group Assignment

Conditions
-----------------
Bone Loss, Alveolar Bone Resorption

Intervention / Treatment
-----------------
* Device: Socket Preservation - Bond Apatite synthetic bone substitute
* Procedure: Socket healing - No Filler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 or over requiring extraction of teeth in the premolar region and anterior maxilla (15-25), presence of intact 2/3 or less, buccal bone plate ASA (Physical Status Classification System, American Society of Anesthesiologist) I or II. Exclusion Criteria: patients with uncompensated systemic diseases, metabolic and healing disorders, i.e. diabetes mellitus, hyperparathyroidism, cancer, HIV, heavy smokers (>5 cigarettes/ day), bone metabolic diseases, severe renal dysfunction or liver disease, had received systemic corticosteroids or other immunosuppressive agents, radiation therapy and/or chemotherapy for the past 2 months, active infections in the surgical site patients with periodontal or/and endodontic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Case Series of 10 consecutive cases , with one extraction (at least ) with a type 2 socket, Control group, 10 consecutive dental extractions.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Socket Preservation Alloplastic Material<br>10 Consecutive Patients with hopeless teeth and 1/3 or more buccal bone resorption will be placed in a therapy go bone regeneration called socket preservation technique. The surgery will include placement of 2/3 biphasic calcium sulfate cement matrix's with hydroxyapatite (HA granules) to fill the alveolar defects, and place a resorbable membrane sutured to adjacent tissue, to avoid material leakage. No flap retraction. 3 Month later an implant will be placed, and a bone biopsy of the healed socket harvested. 2 Month later a final Zirconia ceramic crown screw retained to the osseointegrated implant. Primary (T0) and Secondary (T1) stability measured with ISQ values. Intraoral Scanner and an STL File will be taken at T0 , T1 and T2 for volumetric alteration evaluation. | Device: Socket Preservation - Bond Apatite synthetic bone substitute<br>* 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.<br>* Other names: bone regeneration;|
| Active Comparator: Extraction Socket Spontaneous Healing<br>10 Consecutive patients with a tooth extraction without the aim of placing a future implant and without Biomaterial filler placed in the socket. Spontaneous healing | Procedure: Socket healing - No Filler<br>* 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.<br>* Other names: Alveolar Socket spontaneous healing;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic Examination Histomorphometric Analysis | Histologic measure, percentage of Vital Bone formation, Fibrous/connective tissue, and material remnant present in the sample. | 3 month after tooth extraction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric Changes Clinical | Measure Linear changes reverse engineering software (Geomagic Control X, 3D Systems) in mm. | 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 | 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 | 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 | at final treatment (crown insertion) up to 1 year | 
| Implant probing depth | Measure the attachment loss in mm | At implant insertion and At final treatment (crown insertion) up to 1 year | 
| Implant marginal bone loss. | Measure bone position regarding Implant Platform | at implant placement and at final crown insertion (up to 1 year) | 
| Incidence of Survival rate | if the implant is osseointegrated | at dental crown placement (final treatment) up to 1 year |