Performance of Next-X in Alveolar Ridge Preservation

Official title

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

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.

Interventions

• Other Alveolar Ridge Reconstruction
  It will be used a combination of two biomaterials for alveolar ridge preservation

Primary outcome measures

• histological analysis [Time frame: Samples will be collected at 2 and 3 months after the surgical intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Faculdade de Odontologia da USP — São Paulo

Identifiers

NCT: NCT06698276 · Next-X

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗