Conventional Versus Computer-Assisted Dental Anesthesia
24 de julho de 2026 atualizado por: Jose Leonardo Jimenez-Ortiz, University of Montemorelos
Conventional Versus Computer-Assisted Dental Anesthesia: A Pilot Study of a Randomized Clinical Trial
The purpose of this clinical trial was to compare two methods of delivering local dental anesthesia in undergraduate dental students: a computer-controlled local anesthetic delivery (CCLAD) system and a conventional dental syringe. The study evaluated whether the computer-controlled system reduced pain during the administration of local anesthesia compared with the conventional technique.
The main questions this study aimed to answer were:
Does a computer-controlled local anesthetic delivery system reduce pain during maxillary buccal infiltration compared with a conventional dental syringe? Are there differences in physiological responses (blood pressure, heart rate, and oxygen saturation) between the two anesthetic delivery methods? Which anesthetic delivery method do participants prefer after experiencing both techniques? Would participants recommend their preferred anesthetic delivery method to others? Participants attended two study visits approximately one week apart. Each participant received local anesthesia using both delivery methods in a randomized order, serving as his or her own control. Pain, dental anxiety, physiological parameters, anesthetic delivery preferences, and willingness to recommend the preferred method were assessed during the study.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
29
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.
Locais de estudo
-
-
Nuevo León
-
Montemorelos, Nuevo León, México, 67530
- University Dental Clinic, Montemorelos University School of Dentistry
-
-
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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Undergraduate dental student enrolled in the Local Anesthesia course at the Montemorelos University School of Dentistry.
- Aged 18 years or older.
- Able and willing to provide written informed consent.
- Willing to attend both study periods.
Exclusion Criteria:
- Pregnancy or lactation.
- Known allergy or contraindication to lidocaine or epinephrine.
- Systemic conditions contraindicating elective dental treatment.
- Use of medications that could alter cardiovascular responses.
- Medical condition that could interfere with pain perception or study participation.
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: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Computer-Controlled Local Anesthetic Delivery
Participants received maxillary buccal infiltration anesthesia using a computer-controlled local anesthetic delivery (CCLAD) system during one of two study periods according to the randomized treatment sequence.
Each participant received both study interventions and served as his or her own control.
|
Local anesthetic was administered using a computer-controlled local anesthetic delivery (CCLAD) system with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia.
The device controlled the flow rate throughout anesthetic administration according to the manufacturer's operating protocol.
Outros nomes:
|
|
Comparador Ativo: Conventional Dental Syringe
Participants received maxillary buccal infiltration anesthesia using a conventional aspirating dental syringe during one of two study periods according to the randomized treatment sequence.
Each participant received both study interventions and served as his or her own control.
|
Local anesthetic was administered using a conventional aspirating dental syringe with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia.
Anesthetic administration followed the conventional manual injection technique.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain perception during local anesthetic administration
Prazo: Immediately after each anesthetic administration
|
Pain perceived during maxillary buccal infiltration anesthesia administered with a computer-controlled local anesthetic delivery system or a conventional aspirating dental syringe.
Pain was assessed immediately after each intervention using a 10-cm Visual Analog Scale (VAS), where 0 indicated "no pain" and 10 indicated "worst imaginable pain".
|
Immediately after each anesthetic administration
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Dental anxiety
Prazo: Baseline (before the first study intervention)
|
Dental anxiety was assessed using the Modified Dental Anxiety Scale (MDAS; score range: 5-25).
Higher scores indicate greater dental anxiety.
Assessment was performed before the first study intervention.
|
Baseline (before the first study intervention)
|
|
Systolic and diastolic blood pressure
Prazo: Before, during, and immediately after each anesthetic administration
|
Blood pressure was measured using an automated monitor before, during, and immediately after anesthetic administration.
|
Before, during, and immediately after each anesthetic administration
|
|
Heart rate
Prazo: Before, during, and immediately after anesthetic administration
|
Heart rate was measured using a pulse oximeter before, during, and immediately after anesthetic administration.
|
Before, during, and immediately after anesthetic administration
|
|
Peripheral oxygen saturation (SpO₂)
Prazo: Before, during, and immediately after anesthetic administration
|
Peripheral oxygen saturation was measured using a pulse oximeter before, during, and immediately after anesthetic administration.
|
Before, during, and immediately after anesthetic administration
|
|
Participant-reported preferred anesthetic delivery method
Prazo: Immediately after completion of the second study intervention
|
Participants selected their preferred anesthetic delivery method (computer-controlled local anesthetic delivery system or conventional aspirating dental syringe) after experiencing both interventions.
|
Immediately after completion of the second study intervention
|
|
Willingness to recommend the preferred anesthetic delivery method
Prazo: Immediately after completion of the second study intervention
|
Willingness to recommend the preferred anesthetic delivery method was assessed using an 11-point Numeric Rating Scale (NRS; 0-10), where 0 indicated "not at all willing to recommend" and 10 indicated "extremely willing to recommend."
Higher scores indicate greater willingness to recommend.
Assessment was performed after completion of the second study intervention.
|
Immediately after completion of the second study intervention
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jose L Jimenez-Ortiz, DDS, Montemorelos University School of Dentistry
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)
2 de setembro de 2025
Conclusão Primária (Real)
2 de dezembro de 2025
Conclusão do estudo (Real)
2 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
20 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de julho de 2026
Primeira postagem (Real)
28 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- UM-ESEST-2025-015
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano IPD
A final decision regarding the sharing of de-identified individual participant data has not yet been made.
Data sharing will be considered in accordance with institutional policies, participant confidentiality requirements, and applicable ethical and regulatory standards.
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 .