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Performance of Next-X in Alveolar Ridge Preservation

RecruitingNAAges 18 Years - 80 YearsAllUniversity of Sao Paulo
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In plain words

What the trial is, and whether it could suit you

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 imp

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Alveolar Ridge Reconstruction
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Where

1 site
Faculdade de Odontologia da USP
Sรฃo Paulo, Brazil
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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