Biomaterial Clinical Performance in a Socket Preservation Model

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

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

Inclusion Criteria:

1. Aged 18 or over
2. requiring extraction of teeth in the premolar region and anterior maxilla (15-25), presence of intact 2/3 or less, buccal bone plate
3. ASA (Physical Status Classification System, American Society of Anesthesiologist) I or II.

Exclusion Criteria:

1. patients with uncompensated systemic diseases, metabolic and healing disorders, i.e. diabetes mellitus, hyperparathyroidism, cancer, HIV,
2. heavy smokers (>5 cigarettes/ day),
3. bone metabolic diseases,
4. severe renal dysfunction or liver disease,
5. had received systemic corticosteroids or other immunosuppressive agents, radiation therapy and/or chemotherapy for the past 2 months,
6. active infections in the surgical site
7. patients with periodontal or/and endodontic disease