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Tissue Reactions to Calcium Silicate

NCT04652323 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2020-12-03

No results posted yet for this study

Summary

The aim of this study was to determine the subcutaneous connective tissue reactions to these new materials.

Materials and Methods These materials were placed in polyethylene tubes and implanted into the dorsal connective tissue of Sprague Dawley rats. The presence of inflammation, edema, necrosis, dystrophic calcification, and thickness of fibrous capsule formation was recorded by histological examination 7, 30, and 60 days after the implantation procedure. Inflammation scores were defined as follows: 0 = no or few inflammatory cells, no reaction, 1 = \<25 cells, mild reaction; 2 = 25 to 125 cells, moderate reaction; and 3 = ≥125 cells, severe reaction. Fibrous capsule thickness, necrosis, and formation of calcification were recorded.

Conditions

  • Dental Materials
  • Mineral Trioxide Aggregate

Interventions

DRUG

Biocompatibility of calcium silicate cements

The presence of inflammation, edema, necrosis, dystrophic calcification, and thickness of fibrous capsule formation was recorded by histological examination 7, 30, and 60 days after the implantation procedure of materials.

Sponsors & Collaborators

  • Eskisehir Osmangazi University

    lead OTHER

Principal Investigators

  • Seçil Çalışkan · Eskişehir Osmangazi University

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-04-01
Completion
2020-08-01
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

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 NCT04652323 on ClinicalTrials.gov