Evaluating a method for preserving jawbone after tooth extraction

Clinical and Histological Assessment of a Bone Substitute Enriched With Bioactive Glass for Ridge Preservation

This study is testing a new way to keep the jawbone strong after tooth removal to see if it helps people get better dental implants later on.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Sao Paulo (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06698276 on ClinicalTrials.gov

What this trial studies

This study aims to assess the clinical and histological outcomes of a protocol designed for managing hopeless teeth, specifically focusing on alveolar ridge preservation and the subsequent placement of dental implants. Participants will undergo the atraumatic extraction of single-rooted teeth, followed by immediate treatment with biomaterials to preserve the alveolar bone. The study will evaluate the effectiveness of these biomaterials in maintaining bone structure and quality, as well as the long-term success of dental implants and prosthetic reconstructions over a one-year follow-up period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 requiring extraction of a single-rooted tooth due to various dental issues, with adequate oral hygiene and neighboring teeth present.

Not a fit: Patients who smoke, have uncontrolled metabolic disorders, or are undergoing prolonged corticosteroid therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the success rates of dental implants and improve patient outcomes in tooth restoration.

How similar studies have performed: Previous studies have shown promising results with similar approaches in alveolar ridge preservation, indicating potential for success.

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.

Where this trial is running

São Paulo, São Paulo

• Faculdade de Odontologia da USP — São Paulo, São Paulo, Brazil (RECRUITING)

Study contacts

• Study coordinator: Giuseppe A Romito

Conditions: Hopeless Tooth, prospective case series