Performance of Next-X in Alveolar Ridge Preservation

University of Sao Paulo20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hopeless Tooth

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

histological analysis

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.

Time frame: Samples will be collected at 2 and 3 months after the surgical intervention