이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy

2026년 6월 28일 업데이트: Rania Fathy Mohammed Mohammed, Cairo University

Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy :(A Randomized Clinical Trial)

Preserving primary teeth is essential for maintaining normal chewing, speech development, and psychological well-being. Successful pulpectomy depends on effective chemomechanical preparation of the root canals while preserving their original anatomy. Although hand files are traditionally used for canal preparation in primary teeth, they are time-consuming and may increase the risk of procedural errors. Nickel-titanium (Ni-Ti) rotary systems have gained popularity because they improve canal shaping and reduce instrumentation time. Among these systems, Pediatric NiTi rotary files manufactured with AF-H Wire technology and Pediatric NiTi rotary files manufactured with blue Wire technology are specifically designed for pediatric use. However, evidence regarding their clinical performance remains limited, highlighting the need to compare their effectiveness, particularly in terms of instrumentation time and obturation quality

연구 개요

상태

아직 모집하지 않음

정황

치수절제술

개입 / 치료

연구 유형

중재적

등록 (추정된)

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Rania F. Mohamed, bachelor
전화번호: +01000416751
이메일: rania.fathy@dentistry.cu.edu.eg

참여기준

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

자격 기준

공부할 수 있는 나이

어린이

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

Healthy Cooperative children.
Children between the ages of four and eight years.
Restorable teeth with irreversible pulpitis.
Continuous bleeding after amputation of coronal pulp tissue.

Exclusion Criteria:

Molars that exhibit physiologic root resorption in excess of one-third.
Internal and external root resorption.
Presence of dental abscess, sinus tract or excessive mobility.
Acute spreading infection/cellulitis not manageable with local treatment.
Large periapical/furcation lesion with poor prognosis.
Teeth close to natural exfoliation.
Children with known allergies to study materials or medications used.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 더블

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
활성 비교기: Pediatric NiTi rotary files manufactured with AF-H Wire technology Pediatric NiTi rotary files manufactured with AF-H Wire technology are designed to improve flexibility and cyclic fatigue resistance while facilitating efficient canal preparation. Clinical studies have reported significantly reduced instrumentation time using this rotary system compared with conventional hand instrumentation. Furthermore, the system has demonstrated favorable canal shaping ability and a high percentage of optimally obturated canals, indicating its effectiveness in pediatric pulpectomy procedures	장치: Pediatric NiTi rotary files manufactured with AF-H Wire technology After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using pediatric NiTi rotary files manufactured with AF-H Wire technology with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex and zinc oxide eugenol, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.
실험적: Pediatric NiTi rotary files manufactured with blue wire technology Pediatric NiTi rotary files manufactured with blue wire technology are a newer pediatric rotary system developed using blue heat-treated NiTi technology. Heat treatment enhances flexibility, resistance to cyclic fatigue, and fracture resistance, which are important characteristics when preparing the curved canals of primary teeth. Laboratory studies have shown that blue wire pediatric rotary files exhibit excellent mechanical properties and superior cyclic fatigue resistance compared with several other pediatric rotary systems. However, clinical evidence evaluating its performance in terms of instrumentation efficiency and obturation quality remains limited.	장치: Pediatric NiTi rotary files manufactured with blue wire technology After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using blue technology wire rotary files with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.

참가자 그룹 / 팔

개입 / 치료

활성 비교기: Pediatric NiTi rotary files manufactured with AF-H Wire technology

Pediatric NiTi rotary files manufactured with AF-H Wire technology are designed to improve flexibility and cyclic fatigue resistance while facilitating efficient canal preparation. Clinical studies have reported significantly reduced instrumentation time using this rotary system compared with conventional hand instrumentation. Furthermore, the system has demonstrated favorable canal shaping ability and a high percentage of optimally obturated canals, indicating its effectiveness in pediatric pulpectomy procedures

장치: Pediatric NiTi rotary files manufactured with AF-H Wire technology

After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using pediatric NiTi rotary files manufactured with AF-H Wire technology with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex and zinc oxide eugenol, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.

실험적: Pediatric NiTi rotary files manufactured with blue wire technology

Pediatric NiTi rotary files manufactured with blue wire technology are a newer pediatric rotary system developed using blue heat-treated NiTi technology. Heat treatment enhances flexibility, resistance to cyclic fatigue, and fracture resistance, which are important characteristics when preparing the curved canals of primary teeth. Laboratory studies have shown that blue wire pediatric rotary files exhibit excellent mechanical properties and superior cyclic fatigue resistance compared with several other pediatric rotary systems. However, clinical evidence evaluating its performance in terms of instrumentation efficiency and obturation quality remains limited.

장치: Pediatric NiTi rotary files manufactured with blue wire technology

After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using blue technology wire rotary files with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
instumentation time 기간: same visit while performing the pulpectomy	The total instrumentation time will be recorded from the start of the procedure until the canals are fully prepared. Timing will begin with the insertion of the first file and will end after the final irrigation. It will be measured in minutes using a stopwatch	same visit while performing the pulpectomy

2차 결과 측정

결과 측정	측정값 설명	기간
obturation quality 기간: same visit after pulpectomy completion	The quality of obturation will be evaluated according to the criteria of Coll and Sadrian criteria (1996). The apical seal will measured in millimeters from the apical end of the canal filling material to the radiographic apex and scored as 1, 2, or 3. Apical seal Score 1 (Underfilling): was defined as filling in all canals extending more than 2 mm short of the apex. Score 2 (Ideal filling) was considered when the material reached up to 2 mm short of the radiographic apex or reached the working length in one or more canals. Score 3 (Overfilling) was recorded when the obturating material extended beyond the radiographic apex. Voids Obturated canals will be assessed for the presence or absence of voids.	same visit after pulpectomy completion

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Cairo University

수사관

연구 책임자: Sara A. Mahmoud, Professor, Cairo University

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 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 9월 1일

연구 등록 날짜

최초 제출

2026년 6월 20일

QC 기준을 충족하는 최초 제출

2026년 6월 24일

처음 게시됨 (실제)

2026년 6월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 28일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

CU-rania-2026

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy