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

Not Applicable

Active, not recruiting

• Conditions: Socket Preservation
• Interventions: Procedure: socket preservation with completely demineralized dentin graft; Procedure: socket preservation with partially demineralized dentin graft

• Registration Number: NCT06251960
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-02-01
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-09
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
socket preservation with completely demineralized dentin graft.	socket preservation with completely demineralized dentin graft	-
socket preservation with partially demineralized dentin graft.	socket preservation with partially demineralized dentin graft	-

Primary Outcome Measures

Name	Time	Method
Bone density:	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 analysis	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.
Histomorphometric evaluation:	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).

Trial Locations

Locations (1)

Heba Elsheikh; 🇪🇬 Mansoura, Egypt