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- Ensaio Clínico NCT07634900
Comparison of the Efficacy of Inferior Alveolar Nerve Block and Digital Anesthesia in Pulpectomy of Mandibular Permanent Molars in Children
This study aims to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in achieving adequate anesthesia in pediatric patients presenting with acute dental pain and requiring emergency endodontic treatment of mandibular permanent molars. Achieving profound anesthesia in such cases can be challenging due to acute inflammation.
Participants will be randomly assigned to receive either conventional IANB or digital anesthesia. Pain perception during the procedure will be assessed using validated pain scales. In addition, physiological parameters including heart rate and blood pressure will be recorded to evaluate the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia.
The findings of this study are expected to provide evidence-based guidance for selecting the most effective and comfortable anesthesia technique in pediatric dental patients.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Achieving effective local anesthesia in pediatric patients presenting with acute dental pain remains a significant clinical challenge, particularly in mandibular permanent molars requiring emergency endodontic treatment. The success of conventional inferior alveolar nerve block (IANB) may be reduced in the presence of acute inflammation, leading to inadequate pain control and increased patient anxiety.
Computer-controlled digital anesthesia systems have been introduced as an alternative technique that allows for a more controlled and consistent delivery of local anesthetic solution. This may improve both patient comfort and the success of anesthesia.
The aim of this randomized clinical study is to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in pediatric patients with acute dental pain requiring emergency endodontic treatment of mandibular permanent molars.
Participants will be randomly allocated into two groups: the IANB group and the digital anesthesia group. All procedures will be performed under standardized clinical conditions. Pain perception during anesthesia administration and treatment will be evaluated using validated pain assessment scales.
In addition to subjective pain evaluation, physiological parameters including heart rate and blood pressure will be recorded to assess the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia.
The results of this study are expected to provide clinically relevant evidence regarding the most effective and comfortable anesthesia technique for pediatric patients, thereby improving treatment outcomes and patient experience.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Nisanur Müdüroğlu, DDS
- Número de telefone: 905434631893
- E-mail: nsnr_mdr@hotmail.com
Estude backup de contato
- Nome: Merve Bilmez Selen, PhD
- Número de telefone: 905457673098
Locais de estudo
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Malatya
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Malatya, Malatya, Turquia (Türkiye), 44280
- Recrutamento
- Inonu University Faculty of Dentistry
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Contato:
- nisanur müdüroğlu
- Número de telefone: 905434631893
- E-mail: nisanur.muduroglu@inonu.edu.tr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Children aged 6-14 years
- Patients presenting with acute dental pain
- Patients requiring emergency endodontic treatment in mandibular permanent molars
- Cooperative patients who allowed clinical procedures
- Patients whose parents/legal guardians provided informed consent
Exclusion Criteria:
- Patients with systemic diseases affecting pain perception
- Patients with known allergy to local anesthetic agents
- Patients who used analgesics within 12 hours before treatment
- Patients with non-restorable teeth
- Patients with a history of behavioral management problems preventing 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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Experimental: Inferior Alveolar Nerve Block Group
Participants receiving conventional inferior alveolar nerve block anesthesia for mandibular permanent molars requiring emergency endodontic treatment.
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Participants requiring emergency endodontic treatment for mandibular permanent molars will receive computer-controlled intraosseous digital anesthesia using the SleeperOne computer-controlled local anesthesia delivery system and 4% articaine hydrochloride with 1:100,000 epinephrine.
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Experimental: Digital Anesthesia Group
Participants receiving computer-controlled digital anesthesia for mandibular permanent molars requiring emergency endodontic treatment.
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Participants requiring emergency endodontic treatment for mandibular permanent molars will receive conventional inferior alveolar nerve block anesthesia using a conventional dental syringe and 4% articaine hydrochloride with 1:100,000 epinephrine.
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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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Anesthesia success during endodontic treatment
Prazo: During the procedure
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Anesthetic success will be defined as completion of endodontic treatment without the need for supplemental anesthesia.
Pain during treatment will be assessed using the Visual Analog Scale (VAS; 0-10) and will be considered in the evaluation of anesthetic success.
Higher VAS scores indicate greater pain perception and lower anesthetic success.
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During the procedure
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Heart rate changes
Prazo: Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
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Heart rate will be recorded at predefined time points to evaluate physiological stress response during anesthesia administration and treatment.
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Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Blood pressure changes
Prazo: Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
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Blood pressure will be measured at predefined time points to assess the physiological stress response associated with the anesthesia techniques.
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Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
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Outros números de identificação do estudo
- 2025/8393
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