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Tissue Reactions to Calcium Silicate

2020년 11월 26일 업데이트: Seçil Çalışkan, Eskisehir Osmangazi University

Subcutaneous Connective Tissue Reactions to New Calcium Silicate Cements: An Animal Study

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.

연구 개요

상세 설명

24 Twenty-four male Sprague Dawley rats weighing 250--300 gr were used in the study. For preliminary study, 1 one rat was used on each experimental day . During the study period, the animals were kept in cages in groups of five and taken to daily care under standard care conditions without restriction ofno feed and water supply restrictions.

ProRoot White MTA, Medcem Pure Portland Cement, and 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. Twenty-one empty polyethylene tubes remained empty to bewere used as in the control group.

Surgical Procedures The rats were anesthetized in an ether jar, followed byand then received intraperitoneal administration of 70- mg/kg ketamine and 10- mg/kg xylazine intraperitoneally. The operation area (backs) of the anesthetizedeach rats were was shaved with a certain razor blade, and the surgical area was disinfected with Betadine skin disinfectant ,. After shaving, the operation area wasand covered with sterile drapes to be exposed. In orderTo induce local hemostasis, operations of 0.5 cc, 0.006- mg/ml 4% articaine containing epinephrine (Ultracaine D-S-Aventis Forte, Istanbul, Turkey) by infiltrating local anesthesia was performedadministered.

Incision lines were determined marked on the dorsal, anterior, and posterior extremities of the experimental animals, two in the anterior and two in the posterior region and two in the posterior region. When determining the incision lines, cCare was taken to keep a distance of at least 2 cm distance between the placed materials to prevent them from being affected . Skin iIncisions of approximately 1 cm length long was performedwere made with the a sterile scalpel in the designated areas. The cCanals were entered through the incision site with a sterile periosteal elevator, and ducts were opened under the skin by blunt dissection approximately 2 cm deep. Subsequently, polyethylene tubules filled with the experimental material according toof the each groups and sterile empty polyethylene tubules for the control groups were placed in the prepared subcutaneous canals. The incision sites were then closed primarily using 3/0 silk sutures. Antibacterial spray was applied on the sutures.

Histological Procedures After surgery, on the 7th, 30th and 60th days, 7seven animals from each group, (21 animals) were euthanized intraperitoneally with high doses of thiopentalsodium (Pental, İ.E. Ulagay Med. San. , Istanbul, Turkey) administered intraperitoneally under ether anesthesia on Days 7, 30, and 60. Then, tThe test tubules placed were then removed together with the surrounding tissues and placed in bottles containing 10% neutral formalin. Paraffin blocks were prepared from test samples fixed in bottles containing 10% formalin for 2 two days. From the tissues embedded in the paraffin blocks, 4- μm serial sections parallel to the long axis of the tube were taken cut with a microtome (Leica SM 2000R, Leica Instruments, Wetzlar, Germany) and stained with hematoxylin and eosin (H&E).

All histological evaluations were performed The tissue samples were histologically examined under an optical microscope (Nikon Eclipse E 600, Nikon Corp., Tokyo, Japan) at 40×x, 100×x, 200×x, and 400×x magnifications. All the slides were examined and rated by a pathologists blinded to all procedures.

연구 유형

관찰

등록 (실제)

24

연락처 및 위치

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연구 장소

      • Eskişehir, 칠면조, 26040
        • Eskisehir Osmangazi University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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  • 성인
  • 고령자

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해당 없음

샘플링 방법

확률 샘플

연구 인구

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

설명

Inclusion Criteria:

  • Male Sprague Dawley rats weighing 250--300 gr

Exclusion Criteria:

-

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Control
Twenty-one empty polyethylene tubes remained empty to bewere used as in the control group.
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.
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.
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.
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.
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.
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Biocompatiblity
기간: 1 year
determine the subcutaneous connective tissue reactions to ProRoot MTA, Medcem MTA and Medcem Pure Portland Cement
1 year

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 4월 1일

기본 완료 (실제)

2020년 4월 1일

연구 완료 (실제)

2020년 8월 1일

연구 등록 날짜

최초 제출

2020년 11월 26일

QC 기준을 충족하는 최초 제출

2020년 11월 26일

처음 게시됨 (실제)

2020년 12월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 12월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 11월 26일

마지막으로 확인됨

2020년 11월 1일

추가 정보

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기타 연구 ID 번호

  • 13.02.2019 / 2019-02/04

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Biocompatibility of calcium silicate cements에 대한 임상 시험

구독하다