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NCT06698276 | NOT YET RECRUITING | Hopeless Tooth

Performance of Next-X in Alveolar Ridge Preservation
Sponsor:

University of Sao Paulo

Information provided by (Responsible Party):

Giuseppe Alexandre Romito

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: 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.

Condition or disease

Hopeless Tooth

Intervention/treatment

Alveolar Ridge Reconstruction

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Clinical and Histological Assessment of a Bone Substitute Enriched with Bioactive Glass for Ridge Preservation
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2025-08-01
Estimated Study Completion Date : 2025-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Performance of Next-X in Alveolar Ridge Preservation

Location Details

NCT06698276

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How to Participate

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Locations

Not yet recruiting

Brazil, SP

USP Faculty of Dentistry

São Paulo, SP, Brazil, 05508-000