Performance of Next-X in Alveolar Ridge Preservation

University of Sao Paulo

Status: Enrolling

Conditions: Hopeless Tooth

Treatments: Other: Alveolar Ridge Reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT06698276

Next-X

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

2 months reopen group

Experimental group

Description:

a biomaterial will be used to alveolar ridge preservation, and after 2 months participants of this group will receive a dental implant

Treatment:

Other: Alveolar Ridge Reconstruction

3 months reopen group

Experimental group

Description:

a biomaterial will be used to alveolar ridge preservation, and after 3 months participants of this group will receive a dental implant

Treatment:

Other: Alveolar Ridge Reconstruction