Biomaterial Clinical Performance in a Socket Preservation Model

NCT04789759 | Unknown DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Loss; Alveolar Bone Resorption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Volumetric Changes Clinical

  at pre-extraction and at final crown insertion up to 1 year

• Radiographic CBCT - Bone evaluation

  at pre-extraction and at final crown insertion up to 1 year

• Primary and Secondary stability

  at implant placement and at dental crown insertion up to 1 year

• Incidence of Implant Success rate

  at final treatment (crown insertion) up to 1 year

• Implant probing depth

  At implant insertion and At final treatment (crown insertion) up to 1 year

Study Arms (2)

Socket Preservation Alloplastic Material

EXPERIMENTAL

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.

Device: Socket Preservation - Bond Apatite synthetic bone substitute

Extraction Socket Spontaneous Healing

ACTIVE COMPARATOR

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

Procedure: Socket healing - No Filler

Interventions

Socket Preservation - Bond Apatite synthetic bone substitute DEVICE

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.

Also known as: alveolar regeneration, bone regeneration

Socket Preservation Alloplastic Material

Socket healing - No Filler PROCEDURE

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.

Also known as: Alveolar Socket spontaneous healing

Extraction Socket Spontaneous Healing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• International Advanced Dentistry, Lisbon: lead

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andre Chen, Phd

  International Advanced Dentistry

  PRINCIPAL INVESTIGATOR

• João Borges, Msc

  International Advanced Dentistry

  STUDY DIRECTOR

• Elena Cervino, Msc

  International Advanced Dentistry

  STUDY CHAIR

• Amos Yahav, DMD

  Augma Bio

  STUDY CHAIR

• Ofir Yahav, DMD

  Augma Bio

  STUDY CHAIR

Central Study Contacts

Andre Chen, Phd

CONTACT

00351919774343; ac@iadlisbon.com

Joana Borges

CONTACT

jfb@iadlisbon.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Person who does the volumetric analysis is blinded, Person who makes data treatment is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Case Series of 10 consecutive cases , with one extraction (at least ) with a type 2 socket, Control group, 10 consecutive dental extractions.

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: March 10, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 10, 2021

Record last verified: 2021-03