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Evaluation of Silica-calcium Phosphate Composite in Socket Augmentation

NCT03897010 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-04-02

No results posted yet for this study

Summary

Ideal bone graft should possess osteogenic, osteoinductive, and osteoconductive properties. Unfortunately, all of these are solely found within the autogenous graft that is available only in limited quantities, and it is associated with substantial post-surgical morbidity, However in this study Silica-calcium phosphate composite (SCPC) confirmed clinically, radiographically, histomorphometricand immunohistochemically the vitality and functionality of the newly formed bone. Histology and immunohistochemistry demonstrated maturation of the newly formed bone as indicated by presence of osteocytes, Haversian systems, blood vessels, compact mineralized collagen type I and high immune staining for osteopontin.

Conditions

  • Ridge Deficiency

Interventions

DEVICE

Socket Graft

5 patients had bilateral decayed upper premolar or anterior teeth, in one side SCPC graft was inserted in socket and in the contralateral site was a control, 5 months months postoperative core biopsies were taken from both grafted sockets and control ungrafted sockets during implant insertion. The biopsy samples from SCPC-grafted and control ungrafted sockets were fixed, decalcified and embedded into paraffin wax. All samples were serially sectioned in serial 5μm-thin sections were stained separately with Hematoxylin and Eosin staining, Sirius red and Mason trichrome and immunostaining with osteopontin.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2019-02-01
Completion
2019-02-15
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897010 on ClinicalTrials.gov