Evaluating a method for preserving jawbone after tooth extraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Faculdade de Odontologia da USP
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Giuseppe A Romito
• Email: garomito@usp.br
• Phone: +551130917833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.