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.

NCT07269990 | Active Not Recruiting Phase 1

• 1 other identifier: 7-CE-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extracting Own Teeth

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

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

ACTIVE COMPARATOR

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

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

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

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

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

Interventions

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

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 1

Comparison of 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 in Group 2

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

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

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 in Group 4

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Foggia: lead

Study Sites (1)

University of Foggia

Foggia, Foggia, 71122, Italy

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: July 3, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-01

Locations

IT (1)