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

Socket Preservation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06251960
• Other study ID #: A01012023OS
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Socket Preservation

Intervention

Procedure:
• socket preservation with completely demineralized dentin graft
socket preservation with completely demineralized dentin graft followed by delayed implant placement after 4 months
• socket preservation with partially demineralized dentin graft
socket preservation with completely demineralized dentin graft followed by delayed implant placement after 4 months

Locations

Country	Name	City	State
Egypt	Heba Elsheikh	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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