3D Instrumentation Versus Rotary Instrumentation
The Effect of 3D Instrumentation Versus Rotary Instrumentation on Postoperative Pain and Bacterial Reduction in Necrotic Oval Canals: A Randomized Clinical Trial
enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed consent.
allocation of the patient to either intervention or control group. After anaesthesia and access cavity, the first root canal sample will be taken. Endodontic treatment will be completed in one visit. The second root canal sample will be taken. Patients will be asked to evaluate their postoperative pain level using VAS scale at 6, 12, 24 hours, and daily up to 5 days. Patients will record the number of analgesics if any taken.
연구 개요
상세 설명
After diagnosing the case as asymptomatic pulp necrosis and confirming that the patient conforms to all eligibility criteria, (R.S) will enroll the patient in the study.
the operator will complete treatment of all cases in single visit as following:
- Anesthetizing the tooth using inferior alveolar nerve block technique
- Removal of Caries and/or coronal restorations completely with sterile bur and rubber dam will be applied.
- Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur .
- (R.S) will take the preinstrumentation root canal sample (S1)
- Confirming the patency of the root canals using stainless steel hand K-files size #10 and #15 . Working length will be determined .
- In the intervention group, (R.S) will perform mechanical preparation in a 3D manner using Xp-endo Shaper single file in an endodontic motor at a speed of 800 rpm and a torque of 1 Ncm.
- In the control group, mechanical preparation will be done using rotary iRace files (#25/0.04, #30/0.04, and #40/0.04) at a speed of 600 rpm and a torque of 1.5 Ncm. The canal will be irrigated and recapitulated after the use of each instrument.
- EDTA gel will be used as a lubricant. The canals will be thoroughly irrigated using 3ml of 2.5% sodium hypochlorite.
- The canal will then be dried by using sterile paper points and then flushed with 5 ml of 5% sodium thiosulfate to inactivate the NaOCl. The postinstrumentation sample (S2) will be taken from the canals.
- Master cones will be fitted to the working length and a radiograph will be taken to ensure proper length.
- (R.S) will complete obturation using AdSeal resin-based root canal sealer .
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Manial
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Cairo, Manial, 이집트, 11553
- Faculty of Oral and Dental Medicine - Cairo University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy Adult patients.
- Age between 20-40 years old.
- Males & Females.
- Asymptomatic necrotic mandibular premolars with or without periapical radiolucency.
- Normal occlusal contact with the opposing teeth.
- Patients accepting to participate in the study.
Exclusion criteria:
- Medically compromised patients
- Pregnant women
- If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively
- Patients reporting bruxism or clenching
Teeth that shows:
- Association with acute periapical abscess and swelling
- Greater than grade I mobility or pocket depth greater than 5mm
- No restorability
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: XP-endo Shaper
The XP-endo Shaper is an innovative single instrument manufactured from Max wire.
Its special ability to shift crystalline structure at body temperature in order to adapt to the root canal wall, has provided a unique instrument with the promise of anatomical shaping.
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mechanical preparation in a 3D manner using Xp-endo Shaper
다른 이름들:
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활성 비교기: iRace
rotary files
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rotary mechanical preparation
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Postoperative Pain
기간: up to 5 days
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Degree of postoperative pain will be measured by the patients using modified VAS
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up to 5 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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intracanal bacterial reduction
기간: 6 hours
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The intra-canal bacterial count will be determined using culture technique in the microbiological department, Cairo University. Samples in RTF vials will be dispersed with vortex for 30 seconds by the laboratory technician. The RTF solution will be serially diluted one-tenth dilution and spiral plated onto the agar medium. The plates will be incubated at 37ₒc aerobically and anaerobically. The resultant anaerobic growth will be quantified by evaluating the colony forming units (CFU) on the agar medium under the microscope and the number of CFU per milliliter of each dilution will be calculated for each sample. |
6 hours
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Incidence of analgesic intake
기간: up to 5 days
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In case of presence of moderate or severe postoperative pain, (R.S) will instruct the patients to take only one capsule of placebo given to him/her at the end of the visit (Powdered milk packed in opaque capsules)
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up to 5 days
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Radwa Emara, Faculty of Oral and Dental Medicine - Cairo University
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
XP-endo Shaper에 대한 임상 시험
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Seyda Ersahan, DDS, PhD완전한
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Zimmer Biomet아직 모집하지 않음
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Jørgen Bjerggaard Jensen완전한