Performance of Next-X in Alveolar Ridge Preservation

NCT06698276 | Recruiting

• 1 other identifier: Next-X
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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:
• Undergo extraction of hopeless teeth using an atraumatic protocol.
• Receive alveolar preservation treatment with biomaterials immediately after extraction.
• Provide a bone biopsy for histological processing before implant placement.
• Undergo dental implant placement and prosthetic reconstruction of the lost tooth.
• Attend follow-up appointments over a 1-year period for clinical and radiographic evaluations.

Conditions

Hopeless Tooth

Keywords

prospective case series

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

2 months reopen group

EXPERIMENTAL

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

3 months reopen group

EXPERIMENTAL

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

Interventions

Alveolar Ridge Reconstruction OTHER

It will be used a combination of two biomaterials for alveolar ridge preservation

2 months reopen group; 3 months reopen group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Faculdade de Odontologia da USP

São Paulo, São Paulo, 05508-000, Brazil

RECRUITING

Central Study Contacts

Giuseppe A Romito

CONTACT

+551130917833; garomito@usp.br

Cristina C Villar

CONTACT

+551130917833; villar@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Periodontics Division

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: December 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

BR (1)