Pain During Infiltration Injection in Anterior Maxillary Region by Transcodent Painless Needle Tips Versus Regular Needle Tips

Официальное название

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

Обзор

This randomized split-mouth controlled clinical trial will compare pain experienced during anterior maxillary infiltration anesthesia using Transcodent painless needle tips and conventional dental needle tips. Sixty adult patients requiring bilateral maxillary anterior infiltration anesthesia will receive injections with both needle types in a randomized order. Pain perception will be assessed immediately after each injection using a 100-mm Visual Analog Scale (VAS). The study aims to determine whether the Transcodent needle tip reduces injection-related pain compared with a conventional needle tip, thereby improving patient comfort during routine dental procedures.

Подробное описание

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.

Вмешательства

• Устройство Transcodent Painless Needle Tip
  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.
• Устройство Conventional Dental Needle Tip
  A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.

Первичные конечные точки

• Pain Score During Anterior Maxillary Infiltration Injection [Срок оценки: Immediately after each injection]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07703410 · SCD-OPER-2026-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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