- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07785973
Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions
Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions: A Randomized Clinical Study
Tissue repair is an essential process that reestablishes tissue integrity and regular function. Nevertheless, different therapeutic factors and clinical conditions may interfere in this process of periapical healing.The success of root canal treatment is affected by the correct choice of clinical protocol.
These factors are dependent on the sanitization process (instrumentation, irrigating solution, irrigating strategies, and intracanal dressing) the apical limit of the root canal preparation and obturation, and the quality of the sealer. The challenges affecting the healing process of endodontically treated teeth include control of the inflammation of pulp or infectious processes and simultaneous neutralization of unpredictable provocations to the periapical tissue.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The goal of root canal obturation is to obtain complete sealing to hinder the communication between the root canal and the periapical tissue. This favors the process of apical and periapical repair after endodontic therapy.An ideal root canal sealer must have adequate physical, chemical, and biological properties.
Several factors can affect the success of RCT, including the type and composition of sealer utilized. The presence and release of substances from the sealers can cause different reactions when in contact with tissue.
AH Plus, an epoxy resin-based sealer, is considered the gold standard among root canal sealers due to its excellent physical, chemical, and biological properties. However, the biocompatibility of this sealer remains a subject of debate, as some studies raise concerns about potential inflammatory responses or cytotoxic effects associated with resin-based sealers.
Recent advancements have introduced bioceramic-based sealer composed of zirconium oxide, calcium silicates, calcium phosphates, and calcium hydroxide. This sealer is available in pre-mixed syringes for easy application and exhibit hydrophilic properties, allowing for setting reactions in a moist environment within the root canal, thus preventing shrinkage. Moreover, bioceramic-based sealers exhibit favorable biocompatibility due to their similarity to dentin and ability to stimulate mineralization.
NeoSealer Flo (NeoFlo, NuSmile, Houston, TX, USA) is a ready-to-use bioceramic root canal sealer. According to the manufacturer, it has hydroxyapatite formation ability, biocompatibility, dimensional stability, and antimicrobial activity. NeoFlo has adequate physicochemical properties and releases biologically active ions, such as calcium and phosphate. The addition of cetrimide to NeoSealer Flo promoted a greater inflammatory reaction, but the reduction of inflammatory cells and rearrangement of connective tissue suggests that NeoSealer Flo and the associations with cetrimide are biocompatible and have bioactive potential.
Endodontic treatment comprises the overall management of pre-, intra- and post-operative symptoms, including post-operative endodontic pain, considered as a complication susceptible to chronicization. Post-operative pain is very common and highly unpreventable and has a multifactorial etiology and a potential pathogenic link to the acute inflammation of the periapical area, secondary to localized chemical, mechanical, host and/or microbial damage occurring during endodontic treatment.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Allaa Mohamed Kamel Mohamed, MSC
- Número de telefone: +201006767773
- E-mail: allaa91mk@gmail.com
Estude backup de contato
- Nome: Maged Mohamed Negm, professor
- E-mail: drmagednegm@gmail.com
Locais de estudo
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Minya, Egito
- Recrutamento
- Minia University, Faculty of Dentistry
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Contato:
- Ahmed Ali Yossef, Lecturer
- Número de telefone: +201007335293
- E-mail: ahmed.yousef@mu.edu.eg
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Patients with mature permanent teeth.
- Patients with apical periodontitis.
- Maxillary anterior teeth only will be involved.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow-up period.
- The selected teeth should have periapical lesion score ≤3
Exclusion Criteria:
- Patients with immature canals.
- Patients with swelling.
- Pregnant females.
- Patients who could/would not participate in a 1-year follow-up.
- Geriatric patients.
- Patients with old age.
- Teeth with periodontal involvement.
- Teeth with vertical root fractures.
- Non-restorable teeth.
- cases with previously initiated endodontic treatment.
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 |
|---|---|
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Comparador Ativo: AH plus sealer
About 15 cases will undergo the AH plus sealer during obturation After complete preparation of the root canal system
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to evaluate and compare postoperative pain and periapical healing after root canal treatment using two different base endodontic sealers:
Outros nomes:
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Comparador Ativo: NeoSEALER FLO
About 15 cases will undergo the Neo Sealer FLO during obturation After complete preparation of the root canal system
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to evaluate and compare postoperative pain and periapical healing after root canal treatment using two different base endodontic sealers:
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Tratamento da dor pós -operatória
Prazo: de 0 horas a 2 semanas após o procedimento
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Os pacientes serão avaliados quanto à dor pós -operatória via (NRS) para registrar a intensidade da dor.
segue -se: 0 A leitura representa "sem dor"; 1- 3 A leitura representa "dor leve"; 4- 6 A leitura representa "dor moderada" e 7-10 Leitura representa "dor intensa".
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de 0 horas a 2 semanas após o procedimento
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Cura periapicais
Prazo: Após 6 meses a 12 meses
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A cicatrização periapical será avaliada comparando o tamanho da lesão inicial pré-operatório e pós-operatório (após 6 e 12 meses), usando radiografias periapicais e CBCT.
Isso será agregado em porcentagem (%).
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Após 6 meses a 12 meses
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Maged Mohamed Negm, M.D, Professor of Endodontics, Faculty of Dentistry,Cairo University
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
- NeoSEALER FLO & AH plus sealer
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