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Performance of Next-X in Alveolar Ridge Preservation

Performance of Next-X in Alveolar Ridge Preservation

Recruiting
18-80 years
All
Phase N/A

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Overview

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.

Eligibility

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 details
    Hopeless Tooth

NCT06698276

University of Sao Paulo

7 September 2025

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