Actively Recruiting
Performance of Next-X in Alveolar Ridge Preservation
Led by University of Sao Paulo · Updated on 2024-12-06
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Performance of Next-X in Alveolar Ridge Preservation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults between 18 and 80 years of age
- Need for single-rooted tooth extraction due to caries, fractures, restorative or endodontic issues, orthodontic or prosthetic reasons
- Presence of at least one neighboring tooth adjacent to the extraction site
- Good oral hygiene with bleeding on probing less than 20% and plaque index less than 20%
- At least 50% of the buccal bone plate present
- Classified as ASA I or II according to the American Society of Anesthesiologists
You will not qualify if you...
- Smokers or users of smoking alternatives
- Heavy alcohol drinkers consuming more than 60 g of alcohol per day on average
- Uncontrolled metabolic disorders such as diabetes, osteomalacia, thyroid disorders, severe kidney or liver disease
- Prolonged corticosteroid therapy
- Immunological diseases causing impaired immunity
- History of cancer, radiotherapy, or chemotherapy within the past 5 years
- General contraindications for dental or surgical treatment, including use of anticoagulants or antiresorptives
- Diseases affecting bone metabolism
- Women of child-bearing age not using effective birth control
- Pregnancy or breastfeeding
- Use of medications affecting sinus healing, such as topical steroids or high doses of anti-inflammatory drugs
- Acute or chronic oral infections or uncontrolled periodontal disease
- Crestal bone defects at implant site requiring additional bone augmentation
- Allergy to collagen
- Participation in another investigational drug or device trial within the last 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Faculdade de Odontologia da USP
São Paulo, São Paulo, Brazil, 05508-000
Actively Recruiting
Research Team
G
Giuseppe A Romito
CONTACT
C
Cristina C Villar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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