Evaluation of Bone Behavior in Maxillary Post-extractive Sites Treated With Guided Bone Regeneration (G.B.R.) Techniques in Alveolar Socket Preservation (A.S.P.) Procedures With Different Autologous and Heterologous Biomaterials.

University of Foggia

Status and phase: Active, not recruiting; Phase 1

Conditions: Extracting Own Teeth

Treatments: Procedure: The aim is to compare different types of biomaterials 4 months after application through the use of ASP; Biological: Comparison different types of biomaterials 4 months after application through the use of ASP; Procedure: Comparison of different types of biomaterials 4 months after application through the use of ASP; Procedure: compare different types of biomaterials 4 months after application through the use of ASP compare different types of biomaterials 4 months after application through the use of ASP Group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT07269990

7-CE-2023

Details and patient eligibility

About

The maxillary bone atrophies from traumatic, pathological events or related to physiological bone loss after tooth extraction, promoting a decrease in bone volume (vertical-horizontal) which has always been a crucial challenge for the clinician in order to obtain adequate rehabilitations prosthetics.

The results of bone loss induced aesthetic and functional difficulties in achieving surgical and prosthetic rehabilitation of the right dental implant.

Bone loss can be restored with autologous bone grafts and in large bone atrophy of the jaws require complex surgical techniques such as vascularized bone transplantation.

As an alternative to the reconstruction of the maxillary tissue, several surgical techniques have been promoted to prevent or minimize bone resorption through market biomaterials with or without the patient's autologous bone.

To reduce or counteract biological bone resorption, surgeons have promoted alveolar cavity preservation procedures (ASP) with autologous or heterologous graft materials.

Recently, several studies have been published to evaluate the use of demineralized dentin material derived from the extracted tooth to obtain new bone in the maxillary post-extraction site.

The aim of the study is to compare different types of biomaterials 4 months after application through the use of the alveolar socket preservation technique.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy patients.
• Diagnosis of tooth extraction in the upper or lower jaw.
• Preservation procedures necessary to preserve jawbone volume with Guided
• Bone regeneration with autologous or heterologous biomaterials.

Exclusion criteria

• Patients with high risk of receiving the intervention (pre-existing medical conditions/comorbidities/possible adverse events).
• Patients with conditions that may interfere with the evaluation or confound the results. (e.g. they are already taking treatments)
• Patients with refusal to participate, inability to provide data, or at high risk of loss to follow-up.
• Patients with neoplastic pathologies.
• Patients with Radio-Chemo therapies.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

compare different types of biomaterials 4 months after application through the use of ASP Group 1

Active Comparator group

Treatment:

Procedure: compare different types of biomaterials 4 months after application through the use of ASP compare different types of biomaterials 4 months after application through the use of ASP Group 2

compare different types of biomaterials 4 months after application through the use of ASP Group 2

Active Comparator group

Treatment:

Procedure: Comparison of different types of biomaterials 4 months after application through the use of ASP

compare different types of biomaterials 4 months after application through the use of ASP Group 3

Active Comparator group

Treatment:

Biological: Comparison different types of biomaterials 4 months after application through the use of ASP

compare different types of biomaterials 4 months after application through the use of ASP Group 4

Active Comparator group

Treatment:

Procedure: The aim is to compare different types of biomaterials 4 months after application through the use of ASP

Procedure: The aim is to compare different types of biomaterials 4 months after application through the use of ASP

compare different types of biomaterials 4 months after application through the use of ASP Group 5

Active Comparator group

Treatment:

Procedure: The aim is to compare different types of biomaterials 4 months after application through the use of ASP

Procedure: The aim is to compare different types of biomaterials 4 months after application through the use of ASP