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Influence of Irrigant Delivery Systems on the Incidence of Postoperative Discomfort in Oval Canals

2026년 8월 23일 업데이트: Nourhan Sayid Mohammed, Minia University

Influence of Irrigant Delivery Systems on the Incidence of Postoperative Discomfort in Oval Canals : A Randomized Clinical Trial

The main aim of endodontic therapy is to disinfect the entire root canal system (RCS), which requires the elimination of microorganisms and microbial components. This goal is pursued by chemo-mechanical debridement of the RCS.

Attaining this goal remains challenging due to the complex and variable anatomy of the root canal system, which includes intricate structures such as fins, isthmuses, lateral canals, and apical deltas that are often inaccessible to mechanical instrumentation.

To overcome these anatomical limitations, various irrigation protocols have been developed to enhance the penetration and effectiveness of irrigating solutions.The use of different activation techniques-such as manual dynamic agitation, irrigation needle, sonic and ultrasonic activation, and negative pressure irrigation systems-aims to improve the distribution, exchange, and cleaning ability of irrigants within hard-to-reach areas of the canal system.These approaches are designed to maximize microbial reduction and promote more effective removal of debris and smear layer remnants.

연구 개요

상태

모병

상세 설명

Despite their proven efficacy in improving canal cleanliness and disinfection, these irrigation protocols are not without drawbacks. Mechanical and chemical interactions may lead to extrusion of irrigants or debris beyond the apical foramen, potentially causing irritation of the periapical tissues. As a result, patients may experience varying degrees of postoperative pain or discomfort following treatment, depending on the irrigation method and activation technique employed.

Manual Agitation:

Manual agitation is a simple and cost-effective method used to enhance irrigant penetration and exchange within the root canal system. It involves the use of instruments such as gutta-percha cones or endodontic brushes to manually move the irrigant inside the canal. Although this technique can improve irrigant distribution, its effectiveness is limited by the operator's ability and the lack of continuous flow or activation energy, making it less efficient in complex canal anatomies.

Conventional Needle Irrigation:

Conventional needle irrigation remains the most widely practiced method of delivering irrigants into the canal. Typically, side-vented or open-ended needles are used to dispense the solution within 1-2 mm of the working length. While this technique allows controlled delivery, its major limitation lies in the restricted penetration of irrigant into irregularities and apical areas due to vapor lock and inadequate fluid replacement. Consequently, canal cleanliness and disinfection depend heavily on the needle design, placement depth, and flow rate.

Sonic and Ultrasonic Activation:

Sonic and ultrasonic activation techniques utilize energy transmitted through oscillating tips or files to enhance the dynamic movement of irrigants within the canal. Sonic devices operate at lower frequencies (1-10 kHz), generating acoustic streaming that improves debris removal. Ultrasonic systems function at higher frequencies (25-40 kHz), producing vigorous cavitation and acoustic streaming effects that significantly enhance the cleaning and disinfecting potential of irrigants. However, excessive activation or improper use may increase the risk of irrigant extrusion and subsequent postoperative discomfort.

Negative Pressure Irrigation:

Negative pressure systems, such as the EndoVac or SafeClean, were developed to minimize the risk of apical extrusion and improve irrigant exchange in the apical third.These systems deliver irrigant from the coronal portion while simultaneously applying negative pressure to draw the solution down the canal and aspirate it at the apex. This design enables effective irrigation of the apical region while maintaining safety and preventing periapical irritation.There is limited clinical evidence comparing the effect of different irrigation/activation protocols on postoperative pain in canines and premolars .

연구 유형

중재적

등록 (추정된)

32

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

연구 연락처 백업

연구 장소

      • Minya, 이집트
        • 모병
        • Endodontics Department Faculty of Dentistry
        • 연락하다:

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

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Inclusion Criteria Patients aged between 18 and 45 years.
  • Patients requiring primary root canal treatment.
  • Patients in good general health..
  • Subjects classified as ASA-1 following the classification proposed by the American Society of Anesthesiologists.

Exclusion Criteria:

  • Patients with systemic diseases affecting pain perception or healing.
  • Patients who had taken analgesics or antibiotics within 12-24 hours prior to treatment.
  • Pregnant or lactating women.
  • Previously treated teeth or teeth with root resorption, fractures, or severe periodontal disease. .

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Group of Sodium hypochlorite
About 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% as irrigating solution used as 20 mL irrigant per canal & EDDY sonic activation tips (Device)
to compare the effect of all different irrigation and activation protocols manual agitation, conventional needle irrigation, sonic activation, and negative pressure systems (such as Safe Clean) on the incidence and intensity of postoperative pain following endodontic treatment of canines and premolars
다른 이름들:
  • Sonic activation, and negative pressure systems
활성 비교기: Group of Safe Clean system (Device)
About 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% & Apical Negative Pressure Irrigation using Safe Clean system
to compare the effect of all different irrigation and activation protocols manual agitation, conventional needle irrigation, sonic activation, and negative pressure systems (such as Safe Clean) on the incidence and intensity of postoperative pain following endodontic treatment of canines and premolars
다른 이름들:
  • Sonic activation, and negative pressure systems
활성 비교기: Group of Sodium hypochlorite & manual agitation technique
About 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% & manual agitation technique with apical master gutta percha cone (Device)
to compare the effect of all different irrigation and activation protocols manual agitation, conventional needle irrigation, sonic activation, and negative pressure systems (such as Safe Clean) on the incidence and intensity of postoperative pain following endodontic treatment of canines and premolars
다른 이름들:
  • Sonic activation, and negative pressure systems
활성 비교기: Group of Sodium Hypochlorite & Side vented needle (Device)
About 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% & side vented needle (Device)
to compare the effect of all different irrigation and activation protocols manual agitation, conventional needle irrigation, sonic activation, and negative pressure systems (such as Safe Clean) on the incidence and intensity of postoperative pain following endodontic treatment of canines and premolars
다른 이름들:
  • Sonic activation, and negative pressure systems

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Post-operative pain
기간: 7 Days
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 will indicate "no pain" and 10 will indicate "worst imaginable pain." Participants will be instructed to record their pain intensity at 6, 12, 24, 48,and 72 hours, and on the 7th day after treatment. All recorded pain scores will be collected for statistical analysis and comparison among the study groups
7 Days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 의자: Dalia Ali Ahmed Moukarab, M.D, Professor and Head of the Endodontics Department, Faculty of Dentistry

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)

2026년 4월 14일

기본 완료 (추정된)

2027년 4월 1일

연구 완료 (추정된)

2027년 4월 14일

연구 등록 날짜

최초 제출

2026년 8월 16일

QC 기준을 충족하는 최초 제출

2026년 8월 23일

처음 게시됨 (실제)

2026년 8월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 23일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

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. .

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