Performance of Next-X in Alveolar Ridge Preservation
Recruiting now · Not applicable
Conditions studied: Hopeless Tooth
In brief
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.
Key facts
- Study ID
- NCT06698276
- Run by
- University of Sao Paulo
- People needed
- 20
- Starts
- 2024-12-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-12-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Faculdade de Odontologia da USP — São Paulo, São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
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