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NCT03897010

Evaluation of Silica-calcium Phosphate Composite in Socket Augmentation

Completed Phase 4 Last updated 2 April 2019
What this trial tests

Phase 4 trial testing Socket Graft in Ridge Deficiency in 5 participants. Completed in 15 February 2019.

Timeline
20 November 2017
Primary endpoint
1 February 2019
15 February 2019

Quick facts

Lead sponsorAin Shams University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment5
Start date20 November 2017
Primary completion1 February 2019
Estimated completion15 February 2019
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Ain Shams University

Who can join

Adults 20 to 45, any sex, with Ridge Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Bone regeneration and graft material resorption in extraction sockets grafted with bioactive silica-calcium phosphate composite (SCPC) versus non-grafted sockets: clinical, radiographic, and histological findings.
    Adel-Khattab D, Afifi NS, Abu El Sadat SM, Aboul-Fotouh MN, et al · · 2020 · cited 9× · PMID 33350181 · DOI 10.5051/jpis.2000040002

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