RecruitingPhase 1Phase 2NCT06827665

Clinical and Radiographic Evaluation of Allogenic Dentin Grafts for Alveolar Ridge Preservation

Clinical and Radiographic Evaluation of Allogenic Dentin Grafts for Alveolar Ridge Preservation: A Prospective Clinical Trial


Sponsor

Jordan University Hospital

Enrollment

10 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

For the first time, allografts from human-extracted teeth will be prepared and evaluated in a prospective clinical trial to assess their efficacy for alveolar ridge preservation. The reconstruction and preservation of the alveolar ridge after tooth extraction are essential for future prosthetic rehabilitation. Autogenous bone grafts, while effective, are limited by donor site morbidity and insufficient graft quantity. Allogenic dentin grafts from healthy human donors present a scalable solution. This study aims to evaluate the biocompatibility and effectiveness of two types of allogenic dentin grafts-demineralized dentin allografts (DDA) and whole tooth allografts (WTA)-for alveolar ridge preservation, contributing to innovative, sustainable dental practices.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria7

  • Students, interns, or residents willing to participate and provide informed consent.
  • No history of systemic diseases such as diabetes, hepatitis, or immune disorders.
  • Negative blood screening for HIV, HBV, and HCV.
  • Non-smokers or individuals who have not smoked within the last six months.
  • Patients aged 18-60 years, requiring extraction of at least three teeth for clinical or therapeutic reasons.
  • Patients in good systemic health without conditions that impair bone healing.
  • Willingness to provide informed consent and participate in follow-ups.

Exclusion Criteria14

  • History of systemic conditions affecting oral or overall health.
  • Positive blood tests for communicable diseases.
  • Active oral infections or untreated dental caries.
  • Pregnant or lactating individuals.
  • Individuals with a history of smoking or substance abuse within the last six months.
  • Systemic conditions such as diabetes, osteoporosis, or immunodeficiency that could impair bone regeneration.
  • Active oral infections at extraction sites.
  • History of radiation therapy to the head and neck region.
  • Smoking or smoking history within the last six months.
  • Use of medications affecting bone metabolism (e.g., bisphosphonates, steroids).
  • Pregnancy or lactation. Additional Justification for Extraction: Teeth chosen for extraction must meet one or more criteria:
  • Severe periodontal disease.
  • Irreversible pulpitis or structural damage.
  • Non-restorable condition impacting oral health or functionality.

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Interventions

BIOLOGICALDDA

: demineralized dentin allografts (DDA) allografts from human extracted teeth will be prepared and evaluated in a prospective clinical trial to assess their efficacy for alveolar ridge preservation. The reconstruction and preservation of the alveolar ridge after tooth extraction are essential for future prosthetic rehabilitation. Autogenous bone grafts, while effective, are limited by donor site morbidity and insufficient graft quantity. Allogenic dentin grafts, derived from healthy human donors, present a scalable solution.

BIOLOGICALWTA

whole tooth allografts (WTA) allografts from human extracted teeth will be prepared and evaluated in a prospective clinical trial to assess their efficacy for alveolar ridge preservation. The reconstruction and preservation of the alveolar ridge after tooth extraction are essential for future prosthetic rehabilitation. Autogenous bone grafts, while effective, are limited by donor site morbidity and insufficient graft quantity. Allogenic dentin grafts, derived from healthy human donors, present a scalable solution.


Locations(1)

Jordan University Hospital

Amman, Jordan

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NCT06827665


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