Clinical trial NCT06698276: Performance of Next-X in Alveolar Ridge Preservation
Official title: Clinical and Histological Assessment of a Bone Substitute Enriched With Bioactive Glass for Ridge Preservation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hopeless Tooth
Keywords: prospective case series
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: histological analysis
timeFrame: Samples will be collected at 2 and 3 months after the surgical intervention
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Odontologia da USP
state: SP
Study officials:
References: