Performance of Next-X in Alveolar Ridge Preservation

Not Applicable

Recruiting

• Conditions: Hopeless Tooth

• Registration Number: NCT06698276
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-20
• Status Verified: 2024-12
• Study Start: 2024-12-01
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
histological analysis	Samples will be collected at 2 and 3 months after the surgical intervention	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.

Trial Locations

Locations (1)

Faculdade de Odontologia da USP; 🇧🇷 São Paulo, SP, Brazil