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

NCT06827665 | Recruiting Phase 1

• 1 other identifier: DDA-WTA-JUH
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Ridge Preservation

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (1)

• 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.

  3 months

Study Arms (3)

DDA

EXPERIMENTAL

demineralized dentin allografts (DDA) will be given for alveolar ridge preservation, contributing to innovative, sustainable dental practices

Biological: DDA

WTA

EXPERIMENTAL

Whole tooth allografts (WTA) will be given for alveolar ridge preservation, contributing to innovative, sustainable dental practices

Biological: WTA

Control

NO INTERVENTION

Control

Interventions

DDA BIOLOGICAL

: 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.

Also known as: demineralized dentin allografts (DDA)

DDA

WTA BIOLOGICAL

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.

Also known as: Whole tooth allografts (WTA)

WTA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Jordan University Hospital: lead
• hanan Jafar: collaborator

Study Sites (1)

Jordan University Hospital

Amman, 00962, Jordan

RECRUITING

MeSH Terms

Interventions

bis(p-chlorophenyl)acetic acid

Central Study Contacts

Soukaina Ryalat, Prof

CONTACT

00962795484463; salryalat@yahoo.com

Hanan Jafar, Dr

CONTACT

0096265355000; hanan.jafar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 14, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)