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Clinical Trials/NCT07269990
NCT07269990
Active, not recruiting
Phase 1

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 Foggia1 site in 1 country30 target enrollmentStarted: July 3, 2023Last updated:

Overview

Phase
Phase 1
Status
Active, not recruiting
Sponsor
University of Foggia
Enrollment
30
Locations
1
Primary Endpoint
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.

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
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

  • 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.

Arms & Interventions

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

Active Comparator

Intervention: 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)

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

Active Comparator

Intervention: 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 Group 3

Active Comparator

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

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

Active Comparator

Intervention: The aim is to compare 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 Group 5

Active Comparator

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Foggia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Filiberto Mastrangelo

Clinical Professor, Principal Investigator

University of Foggia

Study Sites (1)

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