Biomaterial Clinical Performance in a Socket Preservation Model
- Conditions
- Alveolar Bone ResorptionBone Loss
- Interventions
- Device: Socket Preservation - Bond Apatite synthetic bone substituteProcedure: Socket healing - No Filler
- Registration Number
- NCT04789759
- Lead Sponsor
- International Advanced Dentistry, Lisbon
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Socket Preservation Alloplastic Material Socket Preservation - Bond Apatite synthetic bone substitute 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. Extraction Socket Spontaneous Healing Socket healing - No Filler 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
- Primary Outcome Measures
Name Time Method Histologic Examination Histomorphometric Analysis 3 month after tooth extraction Histologic measure, percentage of Vital Bone formation, Fibrous/connective tissue, and material remnant present in the sample.
- Secondary Outcome Measures
Name Time Method Primary and Secondary stability at implant placement and at dental crown insertion up to 1 year Measure the Resonance Frequency Analysis at implants placed in regenerated bone
Incidence of Implant Success rate at final treatment (crown insertion) up to 1 year Measure implant status peri-implant parameters , bleeding on probing in percentage of sites
Radiographic CBCT - Bone evaluation at pre-extraction and at final crown insertion up to 1 year Measure Linear changes in bone from T0 baseline to Implant Placement T1 in mm
Implant probing depth At implant insertion and At final treatment (crown insertion) up to 1 year Measure the attachment loss in mm
Implant marginal bone loss. at implant placement and at final crown insertion (up to 1 year) Measure bone position regarding Implant Platform
Incidence of Survival rate at dental crown placement (final treatment) up to 1 year if the implant is osseointegrated
Volumetric Changes Clinical at pre-extraction and at final crown insertion up to 1 year Measure Linear changes reverse engineering software (Geomagic Control X, 3D Systems) in mm.