Biomaterial Clinical Performance in a Socket Preservation Model

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.

Conditions

• Bone Loss
• Alveolar Bone Resorption

Interventions

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.

Sponsors & Collaborators

• International Advanced Dentistry, Lisbon

  lead NETWORK

Principal Investigators

• Andre Chen, Phd · International Advanced Dentistry

• João Borges, Msc · International Advanced Dentistry

• Elena Cervino, Msc · International Advanced Dentistry

• Amos Yahav, DMD · Augma Bio

• Ofir Yahav, DMD · Augma Bio

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-01

Primary Completion

2022-05-01

Completion

2022-08-01