Pain During Infiltration Injection in Anterior Maxillary Region by Transcodent Painless Needle Tips Versus Regular Needle Tips
Comparison of Pain During Infiltration Injection in Anterior Maxillary Region by Transcodent Painless Needle Tips Versus Regular Needle Tips: a Split-mouth Controlled Randomized Clinical Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This randomized split-mouth controlled clinical trial aims to compare pain experienced during anterior maxillary infiltration anesthesia using Transcodent painless needle tips versus conventional dental needle tips. Dental injection pain is a common source of anxiety and may negatively affect patient acceptance of dental treatment. Recent advances in needle design, including the three-edge lancet grinding bevel and silicone-coated cannula of the Transcodent needle, have been developed to reduce tissue resistance during penetration and improve patient comfort.
A total of 60 adult patients requiring bilateral maxillary anterior infiltration anesthesia for dental treatment will be recruited from the Department of Operative Dentistry, Saidu College of Dentistry, Swat. Eligible participants will receive two supraperiosteal injections, one with a Transcodent painless needle tip and one with a conventional needle tip, on opposite sides of the maxillary arch. The order of needle use and injection site will be randomized using a balanced block randomization method. Prior to injection, 20% benzocaine topical anesthetic gel will be applied for two minutes. Each injection will consist of 0.9 mL of 2% lidocaine with 1:100,000 epinephrine administered over 30 seconds by the same operator.
Pain perception will be assessed immediately after each injection using a 100-mm Visual Analog Scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain. The primary outcome is the difference in mean VAS pain scores between Transcodent and conventional needle tips. Data will be analyzed using paired statistical methods appropriate for the distribution of the data.
The findings of this study will provide local evidence regarding the effectiveness of Transcodent painless needle tips in reducing injection-related pain during maxillary infiltration anesthesia and may contribute to improving patient comfort and reducing dental anxiety during routine dental procedures.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Azra Umar, BDS
- Número de telefone: +92 331 8080135
- E-mail: drumarhussain@gmail.com
Locais de estudo
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Mingora Swat, Paquistão, 19200
- Saidu Collage of Dentistry, Saidu Sharif , Swat
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Adults aged 18 to 60 years. Patients requiring bilateral maxillary anterior infiltration anesthesia for dental treatment.
Patients undergoing endodontic procedures involving maxillary canines or premolars.
Presence of healthy maxillary teeth on both sides suitable for infiltration anesthesia.
Individuals with no systemic disease or neurological disorder affecting pain perception.
Ability to understand the study procedures and provide written informed consent.
Both male and female participants.
Exclusion Criteria:
Pregnant or lactating women. Use of analgesics, sedatives, or other pain-modifying medications within the previous 12 hours.
Known allergy or hypersensitivity to local anesthetics, benzocaine, lidocaine, or epinephrine.
Presence of active infection, inflammation, swelling, or pathology at the injection site.
Severe dental anxiety, needle phobia, or inability to cooperate with study procedures.
Individuals unable or unwilling to provide informed consent.
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: Sequence A: Transcodent Needle First
Participants receive anterior maxillary infiltration anesthesia using a Transcodent painless needle tip with a three-edge lancet grinding bevel and silicone-coated cannula.
Pain is assessed immediately after injection using a 100-mm Visual Analog Scale (VAS).
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A dental injection needle with a three-edge lancet grinding bevel and silicone-coated cannula designed to reduce tissue resistance and injection pain during anterior maxillary infiltration anesthesia.
A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.
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Experimental: Sequence B: Conventional Needle First
Participants receive anterior maxillary infiltration anesthesia using a conventional dental needle tip.
Pain is assessed immediately after injection using a 100-mm Visual Analog Scale (VAS).
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A dental injection needle with a three-edge lancet grinding bevel and silicone-coated cannula designed to reduce tissue resistance and injection pain during anterior maxillary infiltration anesthesia.
A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.
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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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Pain Score During Anterior Maxillary Infiltration Injection
Prazo: Immediately after each injection
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Pain perception measured using a 100-mm Visual Analog Scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain.
Pain scores will be recorded immediately after administration of infiltration anesthesia using either a Transcodent
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Immediately after each injection
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Azra Umar, Saidu College of Dentistry, Swat, Paksitan
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- SCD-OPER-2026-06
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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