Effect of Local Anesthesia Techniques on Pulp Hemostasis in Primary Molars
10 de setembro de 2026 atualizado por: Ayça Hande Sari, Afyonkarahisar Health Sciences University
Effect of Mandibular Anesthesia and Computer-Controlled Local Anesthesia on Pulp Hemostasis Time During Pulpotomy Treatment of Mandibular Primary Molars: A Split-Mouth Study
The goal of this clinical trial is to compare the effects of two local anesthesia techniques on pulp hemostasis time during pulpotomy treatment of mandibular primary molars in children aged 6-9 years.
The main questions it aims to answer are:
Does the local anesthesia technique affect the time required to achieve pulp hemostasis during pulpotomy? Are there differences between the two anesthesia techniques in terms of pain, heart rate, and oxygen saturation during treatment?
Researchers will compare conventional inferior alveolar nerve block anesthesia with computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system to determine whether the anesthesia technique affects pulp hemostasis time and the secondary clinical outcomes.
Each participant will receive both anesthesia techniques in a randomized order using a split-mouth design. Participants will:
Receive conventional inferior alveolar nerve block anesthesia for pulpotomy treatment of one mandibular primary molar.
Receive computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system for pulpotomy treatment of the contralateral mandibular primary molar at a separate treatment session.
Have pulp hemostasis time recorded during each pulpotomy procedure. Have pain, heart rate, and oxygen saturation assessed during the treatment procedures.
Visão geral do estudo
Status
Recrutamento
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
40
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.
Contato de estudo
- Nome: Ayça Hande Sari
- Número de telefone: +905065143594
- E-mail: aycahande94@gmail.com
Locais de estudo
-
-
Afyonkarahisar
-
Afyonkarahisar, Afyonkarahisar, Turquia (Türkiye), 03030
- Recrutamento
- Afyonkarahisar Health Sciences University, Faculty of Dentistry
-
Contato:
- Ayça Hande Sari
- Número de telefone: +905065143594
- E-mail: aycahande94@gmail.com
-
-
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
- Filho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Children aged 6-9 years.
- Presence of a pulpotomy indication in both mandibular primary second molars (teeth 75 and 85).
- Systemically healthy children classified as ASA physical status I or II.
- No known coagulation disorders.
- No use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
- Sufficient cooperation and compliance to allow completion of the planned clinical procedures.
- Written informed consent obtained from a parent or legal guardian for participation in the study.
- No history of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.
Exclusion Criteria:
- Children with systemic health conditions classified as ASA physical status III or higher.
- Known allergy or hypersensitivity to the local anesthetic agents or other dental materials used in the study.
- Presence of a known coagulation disorder or use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
- Presence of severe infection, pulp necrosis, advanced root resorption, or any other dental condition requiring a treatment approach other than pulpotomy in the mandibular primary second molars.
- Insufficient cooperation or behavioral difficulties that would prevent completion of the planned clinical procedures.
- History of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.
- Inability to comply with the study protocol or attend the scheduled study visits.
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: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: IANB Followed by Intraosseous Anesthesia
Participants allocated to this sequence will receive conventional inferior alveolar nerve block (IANB) anesthesia for pulpotomy treatment of one mandibular primary molar at the first treatment session.
At the second treatment session, computer-controlled intraosseous anesthesia will be administered for pulpotomy treatment of the contralateral mandibular primary molar.
The time required to achieve pulp hemostasis will be recorded during both treatment sessions.
|
Conventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte).
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue.
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue
|
|
Experimental: Intraosseous Anesthesia Followed by IANB
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol, and the time required to achieve pulp hemostasis will be recorded.
|
Conventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte).
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue.
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pulp Hemostasis Time
Prazo: During pulpotomy, up to 5 minutes after coronal pulp removal
|
The time required to achieve pulp hemostasis following removal of the coronal pulp tissue during pulpotomy will be recorded for each treatment session.
Hemostasis will be assessed using standardized sterile cotton pellets and categorized according to the time required to achieve bleeding control: ≤2 minutes, >2 to 5 minutes, or failure to achieve hemostasis within 5 minutes.
|
During pulpotomy, up to 5 minutes after coronal pulp removal
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Peripheral Oxygen Saturation (SpO₂)
Prazo: Immediately before local anesthesia administration
|
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage (%) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
|
Immediately before local anesthesia administration
|
|
Pain Intensity
Prazo: Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
|
Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale.
Participants will select the face that best represents their perceived pain.
The scale ranges from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity.
Pain will be assessed after administration of local anesthesia and after completion of the pulpotomy procedure.
|
Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
|
|
Heart Rate
Prazo: Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit
|
Heart rate will be measured using a pulse oximeter and recorded as beats per minute (bpm) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
|
Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit
|
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 (Real)
15 de abril de 2026
Conclusão Primária (Estimado)
1 de fevereiro de 2027
Conclusão do estudo (Estimado)
26 de fevereiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
3 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de setembro de 2026
Primeira postagem (Real)
9 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 26.GENEL.013
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data will not be made publicly available due to participant confidentiality and privacy considerations.
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 .