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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04789759
Other study ID # 001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date August 1, 2022

Study information

Verified date March 2021
Source International Advanced Dentistry, Lisbon
Contact Andre Chen, Phd
Phone 00351919774343
Email ac@iadlisbon.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date August 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Socket 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.
Procedure:
Socket 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
International Advanced Dentistry, Lisbon

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary Implant probing depth Measure the attachment loss in mm At implant insertion and At final treatment (crown insertion) up to 1 year
Secondary Implant marginal bone loss. Measure bone position regarding Implant Platform at implant placement and at final crown insertion (up to 1 year)
Secondary Incidence of Survival rate if the implant is osseointegrated at dental crown placement (final treatment) up to 1 year
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