"Effect of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain"
29 de abril de 2020 atualizado por: Istanbul Medipol University Hospital
The Clinical Comparative Evaluation of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain In Retreatment: A Prospective Randomized Clinical Trial
The purpose of this randomized clinical trial is to evaluate the incidence of postoperative pain after retreatment after apical enlargement and sonic activation assisted irrigation.
The presence of postoperative pain will assess after retreatment cases at 12, 24, 48, 72 hrs and 1 week.
Visão geral do estudo
Status
Desconhecido
Descrição detalhada
The aim of this clinical study is to evaluate the intensity and duration of postoperative pain after apical enlargement and sonic activation assisted irrigation procedures.
Patients who have asymptomatic teeth required retreatment will include in this study and retreatment procedure will be applied to these teeth.
One hundreds twenty asymptomatic teeth required retreatment will randomly participate into 4 treatment groups in terms of apical enlargement and sonic activation assisted irrigation procedure applied.
The presence of postoperative pain will assess after 12, 24, 48, 72 hrs and 1 week.
Postoperative pain will be recorded by each patient by using visual analogue pain scale.
Before the treatments, the nature of the study, complications and associated risks will be totally explained and written informed consent will be obtained from all study participants.
The local anesthetic will be applied before the treatment start.
The routine retreatment procedure will be applied.
Different final irrigation solutions will be applied in accordance to the manufacturers' instructions.
At the end of treatment, each patient will be given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week.
After one week the teeth will be examined according to for pain intensity, percussion & palpation sensitivity, swelling, analgesic intake and clinical status.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
120
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
-Patients who were healthy volunteers and who have failed teeth required retreatment with periapical index score 3-5 score requiring root canal treatment for first time.
Patients who were not included the study who;
- were pregnant or breast feeding during the duration of the study,
- have systemic disease, have any pain and/or any facial swelling, abscess,
- were immunocompromised,
- were under 18 yrs. and over 65 yrs. age,
- were taking antibiotics or corticosteroids within previous three days,
- have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral,
- have root canals that could not be well-treated with orthograde retreatment.
Exclusion Criteria:
-The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Apical enlargement
Routine retreatment procedure will be performed at working length according to the apex locator at point "0".
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will be opened.
The working length will be measured using apex locator and the "0" point will be based on.
After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Experimental: Apical enlargement + Sonic Activation Assisted Irrigation
Routine retreatment procedure will be performed at working length according to the apex locator at point "0" and sonic activation assisted irrigation will be applied.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and the "0" point will be based on.
After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals.
Then the teeth were obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Experimental: Non Apical enlargement
Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on.
After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Experimental: Non Apical enlargement + Sonic Activation Assisted Irrigation
Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point and sonic activation assisted irrigation will be applied.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on.
After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals.
Then the teeth were obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
Prazo: Baseline, 12, 24, 48, 72 hours and 1 week.
|
The primary outcome measure of the study is to assess if sonic activation assisted irrigation and apical enlargement procedures influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale.
Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment.
The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm.
Mild pain was defined as greater than 0 mm and less than or equal to 25 mm.
Mild pain included the descriptors of weak and mild pain.
Moderate pain was defined as greater than 50 mm and less than 75 mm.
Intense pain was defined as equal to or greater than 75 mm.
Intense pain included the descriptors of strong, severe, and maximum possible.
|
Baseline, 12, 24, 48, 72 hours and 1 week.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
10 de junho de 2020
Conclusão Primária (Antecipado)
10 de outubro de 2020
Conclusão do estudo (Antecipado)
10 de dezembro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
17 de março de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de março de 2020
Primeira postagem (Real)
19 de março de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de maio de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de abril de 2020
Última verificação
1 de março de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 224 (registration study)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .
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