Alveolar Bone Resorption, Bone Loss
Conditions
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
Interventions
DEVICESocket Preservation - Bond Apatite synthetic bone substitute
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.
PROCEDURESocket healing - No Filler
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.
Sponsors
International Advanced Dentistry, Lisbon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Person who does the volumetric analysis is blinded, Person who makes data treatment is blinded
Intervention model description
Case Series of 10 consecutive cases , with one extraction (at least ) with a type 2 socket, Control group, 10 consecutive dental extractions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
| Implant probing depth | At implant insertion and At final treatment (crown insertion) up to 1 year | Measure the attachment loss in mm |
Contacts
Primary ContactAndre Chen, Phd
Backup ContactJoana Borges
Outcome results
None listed