- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07788027
Influence of Irrigant Delivery Systems on the Incidence of Postoperative Discomfort in Oval Canals
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 .
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Nourhan Sayid Mohammed, B.D.S
- Número de telefone: +201097391219
- E-mail: Nourhansayid02@gmail.com
Estude backup de contato
- Nome: Dalia Ali Ahmed Moukarab, M.D
- Número de telefone: +201068121523
- E-mail: dalia.mokarab@mu.edu.eg
Locais de estudo
-
-
-
Minya, Egito
- Recrutamento
- Endodontics Department Faculty of Dentistry
-
Contato:
- Mohamed Abdel Mawla Mohamed Morsi, Lecturer
- Número de telefone: +201005757045
- E-mail: Dr.mohammed.abdelmawla@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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. .
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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
Outros nomes:
|
|
Comparador Ativo: 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
Outros nomes:
|
|
Comparador Ativo: 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
Outros nomes:
|
|
Comparador Ativo: 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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Post-operative pain
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Dalia Ali Ahmed Moukarab, M.D, Professor and Head of the Endodontics Department, Faculty of Dentistry
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Discomfort in oval canals
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .