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Active, not recruitingNCT06251960Updated Mar 26, 2024

Demineralized Dentin Graft in Preservation of Post-Extraction Sites Associated With Delayed Implant Placement

An interventional study of socket preservation with completely demineralized dentin graft and socket preservation with partially demineralized dentin graft in Socket Preservation, sponsored by Mansoura University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Socket Preservation
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Patients with systemic diseases that interfere with dental implant insertion.
  • Pregnancy.
  • Immunocompromised patients.
  • Existence of non-treated generalized progressive periodontitis.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    socket preservation with completely demineralized dentin graft.

    Procedure: socket preservation with completely demineralized dentin graft

  • Experimental
    socket preservation with partially demineralized dentin graft.

    Procedure: socket preservation with partially demineralized dentin graft

Interventions

  • Proceduresocket preservation with completely demineralized dentin graft

    socket preservation with completely demineralized dentin graft followed by delayed implant placement after 4 months

  • Proceduresocket preservation with partially demineralized dentin graft

    socket preservation with completely demineralized dentin graft followed by delayed implant placement after 4 months

06

What researchers measure

Primary outcomes

  1. Histomorphometric evaluation:

    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).

    Time frame: 4 monhs

  2. Histomorphometric analysis

    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.

    Time frame: 4 months

  3. Bone density:

    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.

    Time frame: 12 months

07

Study locations

1 site
  • Heba Elsheikh
    Mansoura, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06251960
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Feb 9, 2024
Start date
Feb 1, 2024
Primary completion
Jun 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 26, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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