Biomaterial Clinical Performance in a Socket Preservation Model

International Advanced Dentistry, Lisbon

Status: Unknown

Conditions: Alveolar Bone Resorption; Bone Loss

Treatments: Procedure: Socket healing - No Filler; Device: Socket Preservation - Bond Apatite synthetic bone substitute

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04789759

001

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Socket Preservation Alloplastic Material

Experimental group

Description:

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.

Treatment:

Device: Socket Preservation - Bond Apatite synthetic bone substitute

Extraction Socket Spontaneous Healing

Active Comparator group

Description:

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

Treatment:

Procedure: Socket healing - No Filler