NCT06698276 Performance of Next-X in Alveolar Ridge Preservation
| NCT ID | NCT06698276 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Hopeless Tooth |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-12-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06698276 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hopeless Tooth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06698276 currently recruiting?
Yes, NCT06698276 is actively recruiting participants. Contact the research team at garomito@usp.br for enrollment information.
Where is the NCT06698276 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06698276 clinical trial?
NCT06698276 is sponsored by University of Sao Paulo. The trial plans to enroll 20 participants.