Tissue Reactions to Calcium Silicate

NCT04652323 | Completed FDA Drug

• 1 other identifier: 13.02.2019 / 2019-02/04
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Biocompatiblity

  determine the subcutaneous connective tissue reactions to ProRoot MTA, Medcem MTA and Medcem Pure Portland Cement

  1 year

Study Arms (4)

Control

Twenty-one empty polyethylene tubes remained empty to bewere used as in the control group.

Drug: Biocompatibility of calcium silicate cements

ProRoot MTA

ProRoot White MTA mixed according to the manufacturer's' instructions were filled placed into sterile p olyethylene tubules (internal diameter: 1.3 mm internal diameter, x external diameter: 1.6 mm external diameter, x length: 5.0 mm length) sterilized with ethylene oxide gas, as specified by ISO , with using a sterile Llentulo.

Drug: Biocompatibility of calcium silicate cements

Medcem MTA

Medcem MTA mixed according to the manufacturer's' instructions were filled placed into sterile p olyethylene tubules (internal diameter: 1.3 mm internal diameter, x external diameter: 1.6 mm external diameter, x length: 5.0 mm length) sterilized with ethylene oxide gas, as specified by ISO , with using a sterile Llentulo.

Drug: Biocompatibility of calcium silicate cements

Medcem Pure Portland Cement

Medcem Pure Portland Cement mixed according to the manufacturer's' instructions were filled placed into sterile p olyethylene tubules (internal diameter: 1.3 mm internal diameter, x external diameter: 1.6 mm external diameter, x length: 5.0 mm length) sterilized with ethylene oxide gas, as specified by ISO , with using a sterile Llentulo.

Drug: Biocompatibility of calcium silicate cements

Interventions

Biocompatibility of calcium silicate cements DRUG

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.

Control; Medcem MTA; Medcem Pure Portland Cement; ProRoot MTA

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

24 Twenty-four male Sprague Dawley rats weighing 250--300 gr were used in the study.

You may qualify if:

• Male Sprague Dawley rats weighing 250--300 gr

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, 26040, Turkey (Türkiye)

Location

Study Officials

• Seçil Çalışkan

  Eskişehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-11

Locations

TU (1)