Preoperative Dexamethasone Injection to Improve Local Anesthesia Success in Endodontic Treatment

Официальное название

Preoperative Intraligamentary Injection of Dexamethasone Can Improve the Anesthetic Success Rate of 2% Lidocaine During the Endodontic Management of Mandibular Molars With Symptomatic Irreversible Pulpitis

Обзор

This study aims to determine whether giving a single dose of 4mg dexamethasone before root canal treatment can reduce the amount of pain patients experience during the procedure . Patients diagnosed with symptomatic Irreversible Pulpitis requiring endodontic treatment will be enrolled. Participants will receive either dexamethasone or placebo before treatment , and pain during the procedure will be measured using a Visual Analogue Scale (VAS) . The findings may help improve pain management strategies during root canal treatment .

Подробное описание

Symptomatic irreversible pulpitis is a common cause of severe dental pain, and achieving adequate pain control during endodontic treatment remains a challenge despite the use of local anesthesia. Inflammatory mediators present in inflamed pulp tissues may reduce the effectiveness of local anesthetics , resulting in persistent intraoperative pain.

Dexamethasone is a corticosteroid with potent anti-inflammatory properties that may reduce inflammatory mediator release and improve pain control . This randomized controlled clinical trial aims to evaluate the effectiveness of preoperative 4mg dose of dexamethasone compared with placebo in reducing intraoperative pain during endodontic treatment of teeth diagnosed with symptomatic irreversible pulpitis.

Eligible participants will be randomly allocated to receive either dexamethasone or placebo before treatment . Standard local anesthesia and endodontic procedures will be performed for all participants .

Intraoperative pain intensity will be assessed using a Visual Analogue Scale. The primary outcome will be the difference in intraoperative pain scores between the two groups.

The results of this study may provide evidence regarding the role of preoperative dexamethasone as an adjunct for improving pain control during endodontic treatment .

Вмешательства

• Препарат dexamethasone
  participants receive 4mg dexamethasone administered via intraligamental infiltration followed by inferior alveolar nerve block before endodontic treatment of mandibular molars with symptomatic irreversible pulpitis
• Препарат Saline (0.9% NaCl)
  participants receive an equivalent volume of normal saline administered via intraligamental infiltration before root canal treatment for symptomatic irreversible pulpitis

Первичные конечные точки

• Intraoperative pain intensity [Срок оценки: Pain intensity assessed intraoperatively from initiation of access cavity preparation until completion of canal instrumentation during a single visit ( approximately 30-90 minutes).]

Критерии участия

Критерии включения

• Patients with pain VAS >/= 6
• Carious exposed mandibular molar with symptomatic irreversible pulpitis
• Patients between ages 18-60 years
• American Society of Anesthesiologists class I or II medical histories -

Критерии исключения

1\. Patients with contraindications to local anesthesia solution or dexamethasone 2.Pregnant or breast-feeding females 4.Tooth having fused/extra roots, full coverage crowns, or poor periodontal status 5. Patients taking drugs which could affect the pain perception

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07699315 · WMDC/R&D(ERB)/2024/157

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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