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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Extracting Own Teeth
• Intervention / 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; Procedure: Comparison of 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: 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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Italy
  • Foggia
    • Foggia, Foggia, Italy, 71122
      • University of Foggia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: compare different types of biomaterials 4 months after application through the use of ASP Group 1	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; The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 1
Active Comparator: compare different types of biomaterials 4 months after application through the use of ASP Group 2	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
Active Comparator: compare different types of biomaterials 4 months after application through the use of ASP Group 3	Biological: 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
Active Comparator: compare different types of biomaterials 4 months after application through the use of ASP Group 4	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 4; 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
Active Comparator: compare different types of biomaterials 4 months after application through the use of ASP Group 5	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 4; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of different biomaterials at 4 months to assess the percentage of residual biomaterial remaining in situ and the percentage of newly formed bone in the regenerated area.	4 months after surgery

Collaborators and Investigators

• Sponsor: University of Foggia

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 7-CE-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes