Faculdade de Odontologia da USP
São Paulo, 05508-000, Brazil
Location status: Recruiting
Location contact
Cristina C Villar
SUB_INVESTIGATOR
Giuseppe A Romito
PRINCIPAL_INVESTIGATOR
Graziela F Malagutti
CONTACT
Igor S Medeiros
CONTACT
NCT Number: NCT06698276
The goal of this case series study is to evaluate the clinical and histological outcomes of a protocol for managing hopeless teeth, focusing on alveolar preservation and subsequent dental implant placement. The study will also assess the long-term success of prosthetic reconstruction. The main questions it aims to answer are:
* How effective is the use of biomaterials for alveolar preservation in maintaining bone structure and quality? * What are the histological characteristics of the alveolar bone after biomaterial application? * How successful are dental implants and prosthetic reconstructions in restored sites over a 1-year follow-up period?
Participants will:
1. Undergo extraction of hopeless teeth using an atraumatic protocol. 2. Receive alveolar preservation treatment with biomaterials immediately after extraction. 3. Provide a bone biopsy for histological processing before implant placement. 4. Undergo dental implant placement and prosthetic reconstruction of the lost tooth. 5. Attend follow-up appointments over a 1-year period for clinical and radiographic evaluations.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
São Paulo, 05508-000, Brazil
Location status: Recruiting
Cristina C Villar
SUB_INVESTIGATOR
Giuseppe A Romito
PRINCIPAL_INVESTIGATOR
Graziela F Malagutti
CONTACT
Igor S Medeiros
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
It will be used a combination of two biomaterials for alveolar ridge preservation
Time frame: Samples will be collected at 2 and 3 months after the surgical intervention
Histological sections will be stained with hematoxylin-eosin (HE) and Masson's trichrome. A semi-quantitative analysis will be performed by a pathologist (Blinded for the groups), adopting a histological score system (0 - absence, 1- mild; 2 - mild to moderate, 3 - moderate to intense, and 4 - intense). These scores will be determined based on the intensity of the following histological parameters: necrosis, inflammatory infiltrate, fibrosis, biomaterial remnants, new-formed bone trabeculae, and angiogenesis. A histomorphometric analysis will also be performed for the trabecular bone area, cellularity area, and microvessel density.
Contact information is provided by the study sponsor or research team.
Cristina C Villar
CONTACT
Giuseppe A Romito
CONTACT
University of Sao Paulo
Other
Clinical and Histological Assessment of a Bone Substitute Enriched With Bioactive Glass for Ridge Preservation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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