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

February 9, 2025 updated by: Soukaina Ryalat, Jordan University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study holds significant importance for the fields of dentistry and maxillofacial surgery, addressing key clinical, scientific, and practical challenges:

  1. Innovative Approach to Ridge Preservation o By evaluating allogenic dentin grafts for alveolar ridge preservation, this study introduces an innovative solution for post-extraction bone regeneration, offering a sustainable alternative to conventional grafting methods.
  2. Addressing Limitations of Autogenous Grafts o Autogenous bone grafts, while effective, are limited by availability, patient acceptance, and donor site morbidity. Allogenic dentin grafts overcome these limitations, providing a readily available, safe, and effective option.
  3. Sustainable Utilization of Extracted Teeth o Extracted teeth are typically discarded as biomedical waste. This study demonstrates their potential to be repurposed as valuable graft materials, promoting sustainability and reducing waste in dental practices.
  4. Expanding the Body of Knowledge o There is limited research on allogenic dentin grafts compared to autogenous or xenogenic grafts. This study contributes valuable clinical and radiographic data, addressing a significant gap in the literature and paving the way for future research.
  5. Clinical Relevance for Prosthetic Rehabilitation o Successful alveolar ridge preservation is critical for subsequent prosthetic treatments, including implants and dentures. This study provides evidence-based insights into new methods that improve outcomes for patients.
  6. Potential for Broader Applications o By validating the efficacy of allogenic dentin grafts, this research supports the development of standardized protocols for their preparation and use, potentially expanding their application beyond ridge preservation to other bone regeneration procedures.
  7. Encouraging Tissue Banking and Collaboration

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Jordan
      • Amman, Jordan, 00962
        • Recruiting
        • Jordan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion and Exclusion Criteria for Donors:

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Inclusion and Exclusion Criteria for Recipients:

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: DDA
demineralized dentin allografts (DDA) will be given for alveolar ridge preservation, contributing to innovative, sustainable dental practices
Biological: DDA
: 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.
Other Names:
  • demineralized dentin allografts (DDA)
Experimental: WTA
Whole tooth allografts (WTA) will be given for alveolar ridge preservation, contributing to innovative, sustainable dental practices
Biological: WTA
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.
Other Names:
  • Whole tooth allografts (WTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in alveolar ridge width and height (in mm) from baseline to 3 months post-extraction, measured using CBCT scans.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in alveolar crest height and width (in mm) from baseline to 3 months post-extraction, measured using CBCT scans, comparing DDA, WTA, and ungrafted control sites.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University Hospital

Collaborators

hanan Jafar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 9, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • DDA-WTA-JUH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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