Biomaterial Clinical Performance in a Socket Preservation Model

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04789759
• Other study ID #: 001
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Alveolar Bone Resorption
• Bone Loss
• Bone Resorption

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