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.

NCT ID: NCT07269990

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-03

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Extracting Own Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 1

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 2

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 3

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 5

Interventions

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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

The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 1

Intervention Type PROCEDURE

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

The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 2

Intervention Type PROCEDURE

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

The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 3

Intervention Type BIOLOGICAL

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

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

Intervention Type PROCEDURE

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

The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 5

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Foggia

OTHER

Sponsor Role lead

Responsible Party

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Filiberto Mastrangelo

Clinical Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Foggia

Foggia, Foggia, Italy

Site Status

Countries

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Italy

Other Identifiers

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7-CE-2023

Identifier Type: -

Identifier Source: org_study_id