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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Socket Preservation
• Intervention / Treatment: Procedure: socket preservation with completely demineralized dentin graft; Procedure: socket preservation with partially demineralized dentin graft

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Heba Elsheikh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: socket preservation with completely demineralized dentin graft.	Procedure: socket preservation with completely demineralized dentin graft; socket preservation with completely demineralized dentin graft followed by delayed implant placement after 4 months
Experimental: socket preservation with partially demineralized dentin graft.	Procedure: socket preservation with partially demineralized dentin graft; socket preservation with completely demineralized dentin graft followed by delayed implant placement after 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: A01012023OS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No