Performance of Next-X in Alveolar Ridge Preservation

December 3, 2024 updated by: Giuseppe Alexandre Romito, University of Sao Paulo

Clinical and Histological Assessment of a Bone Substitute Enriched With Bioactive Glass for Ridge Preservation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Giuseppe A Romito
  • Phone Number: +551130917833
  • Email: garomito@usp.br

Study Contact Backup

  • Name: Cristina C Villar
  • Phone Number: +551130917833
  • Email: villar@usp.br

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05508-000
        • Recruiting
        • Faculdade de Odontologia da USP
        • Contact:
          • Igor S Medeiros
          • Phone Number: +551130910062
          • Email: igorsm@usp.br
        • Contact:
          • Graziela F Malagutti
          • Phone Number: +5511309167817
          • Email: dirfo@usp.br
        • Principal Investigator:
          • Giuseppe A Romito
        • Sub-Investigator:
          • Cristina C Villar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults between 18 and 80 years of age.
  • Requirement for single-rooted tooth extraction due to reasons such as caries, fractures, restorative issues, endodontic complications (e.g., root fracture, instrument fracture), orthodontic needs, or prosthetic considerations.
  • Presence of at least one neighboring tooth adjacent to the extraction site.
  • Maintaining adequate oral hygiene, indicated by bleeding on probing <20% and plaque index <20%.
  • Presence of at least 50% of the buccal bone plate.
  • Classification of patients as ASA I or II status according to the American Society of Anesthesiologists Classification.

Exclusion Criteria:

  • All smokers, including smoking alternatives.
  • Heavy drinker (> 60 g of alcohol per day as a mean).
  • Uncontrolled metabolic disorders e.g., diabetes mellitus, osteomalacia, thyroid disorder, severe renal or hepatic disorder.
  • Prolonged corticosteroid therapy.
  • Immunological impairment diseases.
  • History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years.
  • General contraindications for dental and/or surgical treatment (including patients who take anticoagulants or antiresorptives).
  • Disease or condition affecting bone metabolism.
  • Women of child-bearing age, not using a highly effective method of birth control.
  • Pregnancy or breast feeding.
  • Previous and concurrent medication affecting sinus healing in general (e.g., topical steroids, large doses of anti-inflammatory drugs).
  • Acute or chronic oral infection or uncontrolled periodontal disease.
  • Crestal bone defects at the implantation site, which require additional bone augmentation around the neck of the implant.
  • Allergy to collagen.
  • Participation in an investigational device or drug clinical trial within the last six month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 2 months reopen group
a biomaterial will be used to alveolar ridge preservation, and after 2 months participants of this group will receive a dental implant
Other: Alveolar Ridge Reconstruction
It will be used a combination of two biomaterials for alveolar ridge preservation
Experimental: 3 months reopen group
a biomaterial will be used to alveolar ridge preservation, and after 3 months participants of this group will receive a dental implant
Other: Alveolar Ridge Reconstruction
It will be used a combination of two biomaterials for alveolar ridge preservation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
histological analysis
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.
Samples will be collected at 2 and 3 months after the surgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Next-X

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data can not be shared without he/she approval.

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings