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

NCT06251960 | Unknown

• 1 other identifier: A01012023OS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Socket Preservation

Outcome Measures

Primary Outcomes (3)

• 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).

  4 monhs

• 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.

  4 months

• 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.

  12 months

Study Arms (2)

socket preservation with completely demineralized dentin graft.

EXPERIMENTAL

Procedure: socket preservation with completely demineralized dentin graft

socket preservation with partially demineralized dentin graft.

EXPERIMENTAL

Procedure: socket preservation with partially demineralized dentin graft

Interventions

socket preservation with completely demineralized dentin graft PROCEDURE

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

socket preservation with completely demineralized dentin graft.

socket preservation with partially demineralized dentin graft PROCEDURE

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

socket preservation with partially demineralized dentin graft.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Heba Elsheikh

Al Mansurah, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-01

Locations

EG (1)