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Clinical Trials/NCT06251960
NCT06251960
Active, not recruiting
Not Applicable

Comparison of Autogenous Completely Demineralized Dentin Graft Versus Partially Demineralized Dentin Graft Used in Preservation of Post-Extraction Sites Associated With Delayed Implant Placement

Mansoura University1 site in 1 country30 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Socket Preservation
Sponsor
Mansoura University
Enrollment
30
Locations
1
Primary Endpoint
Bone density:
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

Thirty patients will be selected from outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University seeking for extraction of non-restorable mandibular posterior teeth For the 1st group: the socket will be grafted with completely demineralized dentin graft after 3 days of extraction, followed by delayed implant placement after 4 months.

For the 2nd group: the socket will be grafted with partially demineralized dentin graft in in the same day of extraction, followed by delayed implant placement after 4 months.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
December 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient medically free from systemic diseases.
  • Patient with good oral hygiene.
  • Age above 18 years.
  • Presence of non-restorable mandibular premolar tooth due to caries, root resorption, roots fracture, etc.
  • No acute infection is present.
  • No history of bruxism.
  • Patients prepared to comply with the follow-up and maintenance program.

Exclusion Criteria

  • Patients with systemic diseases that interfere with dental implant insertion.
  • Pregnancy.
  • Immunocompromised patients.
  • Existence of non-treated generalized progressive periodontitis.

Outcomes

Primary Outcomes

Bone density:

Time Frame: 12 months

Bone density will be evaluated using Cone Beam Computed Tomography (CBCT) that will be made immediately after socket preservation, at 4 months after preservation (just before implant placement), and after 12 months from implant loading.

Histomorphometric evaluation:

Time Frame: 4 monhs

After 4 months of socket preservation and just before implant placement, a trephine bur will be used to collect a core of bone from the preserved socket. Bone will be examined histologically to evaluate the quality and quantity of the formed bone. Briefly, the specimens were fixed with 4% paraformaldehyde in 0.1M PBS (pH 7.4) and decalcified in 0.5M EDTA (pH 7.8). After decalcification, each specimen will be processed and embedded in paraffin, and transverse serial sections of 5 μm thickness will be prepared. The sections will be stained with hematoxylin and eosin (H\&E), Masson's Trichrome (MT) (Cat # HT15, Sigma Aldrich) and immunohistochemical staining with osteocalcin antibody polyclonal osteocalcin (OCN);diagnostic biosystems), histological examination will be carried out using an Olympus BX-51 optical microscope (Olympus Co., Tokyo, Japan).

Histomorphometric analysis

Time Frame: 4 months

Microscopic images of the surgical sites will be taken by randomly selecting four areas of the center portion of the defect at 100× magnification. Then, using 16 images of each group, the ratio of newly formed bone to the entire defect area in the slide images will be calculated in trichrome and osteocalcin-stained images using the Intel® Core I7® based computer using VideoTest Morphology® software (Russia) with a specific built-in routine for % area, measurement.

Study Sites (1)

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