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NCT Number: NCT06698276

Performance of Next-X in Alveolar 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.

Recruiting

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alveolar Ridge Reconstruction

Other

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina C Villar

CONTACT

[email protected]

+551130917833

Giuseppe A Romito

CONTACT

[email protected]

+551130917833

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2024
Registry last updated
Dec 6, 2024

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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