Performance of Next-X in Alveolar Ridge Preservation

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: Recruiting
• Conditions: Hopeless Tooth
• Intervention / Treatment: Other: Alveolar Ridge Reconstruction

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
histological analysis	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

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: prospective case series
• Other Study ID 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