Skip to main content
Clinical Trials/NCT03897010
NCT03897010
Completed
Phase 4

Alveolar Ridge Augmentation Using Resorbable Bioactive Silica-calcium Phosphate Composite (SCPC): Clinical and Histology Evaluation

Ain Shams University1 site in 1 country5 target enrollmentNovember 20, 2017

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Ridge Deficiency
Sponsor
Ain Shams University
Enrollment
5
Locations
1
Primary Endpoint
Histological outcome
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

Detailed Description

Alveolar ridge resorption following teeth extraction leads to 50% loss in bone width over one year period which corresponds to 5 -7 mm mainly from the buccal rather than palatal\\lingual aspects. Several calcium phosphates from bovine and synthetics sources are used for preservation of extraction socket; however with variable degrees of success. The aim of the present study is to evaluate clinically, radiographically and histologically the effect of Silica-calcium phosphate composite (SCPC) granules on new bone formation qualitatively and quantitatively following socket augmentation. This case series study was performed in five (n = 5) participants (one male and four females), all participants underwent socket augmentation procedures and dental implant placement in a staged approach. All participants were fully informed about the procedures, including the surgery, bone substitute materials and implants. Each participant had one extraction socket to be grafted with silica-calcium phosphate SCPC dental bone graft granules and the contralateral socket served as ungrafted control. Clinical, radiographic and histological evaluation was assessed.

Registry
clinicaltrials.gov
Start Date
November 20, 2017
End Date
February 15, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Doaa Adel

Lecturer of Periodontology, Faculty of Dentistry

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Patients require extraction of bilateral non-restorable (premolar or anterior) tooth located in the maxillary arch and need implant restoration.
  • Teeth to be extracted are free from acute periapical infection or active periodontitis.
  • Buccal plate of bone is intact
  • Systemic free patients
  • Patients were able to swallow tablets.

Exclusion Criteria

  • Patients with remaining root accompanied with acute periapical infection or sinus tract
  • Insulin dependent diabetes patients.
  • Thyroid disease patients.
  • Smoker´s patients
  • Patients with compromised health (ASA (III or IV) - according to the classification of American Society of Anaesthesiology including drug or alcohol abuse or any significant systemic disease.

Outcomes

Primary Outcomes

Histological outcome

Time Frame: 7 months

histomorphometric measurement of amount of residual graft percent and amount of new vital bone formation in the newly formed bone. The sections were obtained from the core biopsy in 5µm thickness and were stained by Hematoxylin and Eosin.

Clinical outcome

Time Frame: 5 months

Buccolingual bone width was measured by bone caliper 4 mm away from the gingival margins

Secondary Outcomes

  • Immunohistochemical analysis(7 months)

Study Sites (1)

Loading locations...

Similar Trials