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Active, not recruitingNCT07269990Updated Apr 30, 2026

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.

A Phase 1 interventional study of 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 and Comparison of different types of biomaterials 4 months after application through the use of ASP in Extracting Own Teeth, sponsored by University of Foggia. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by University of Foggia · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Extracting Own Teeth
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • Procedurecompare 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

  • ProcedureComparison 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

  • BiologicalComparison 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

  • ProcedureThe 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

  • ProcedureThe 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

05

What researchers measure

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.

    Time frame: 4 months after surgery

06

Study locations

1 site
  • University of Foggia
    Foggia, Foggia 71122, Italy
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07269990
Lead sponsor
University of Foggia
Responsible party
Filiberto Mastrangelo (Clinical Professor, Principal Investigator, University of Foggia) — Principal investigator
First posted
Dec 8, 2025
Start date
Jul 3, 2023
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Apr 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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