Comparative Evaluation of Diclofenac Sodium and Ibuprofen for Post-Endodontic Pain Management (DIPI-PEP)
Comparative Evaluation of the Efficacy of Diclofenac Sodium and Ibuprofen in the Management of Post-Endodontic Pain Following Single-Visit Root Canal Treatment: A Randomized Controlled Trial
This randomized controlled trial aims to compare the effectiveness of Diclofenac sodium and Ibuprofen in reducing pain after root canal treatment. Post-endodontic pain is a common complication following treatment of irreversible pulpitis and may affect patient comfort and recovery. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed to manage postoperative dental pain due to their anti-inflammatory and analgesic properties.
A total of 60 adult participants diagnosed with irreversible pulpitis involving a single first molar will undergo single-visit root canal therapy. Participants will be randomly assigned to receive either diclofenac sodium 50 mg or ibuprofen 400 mg immediately after treatment. Pain levels will be recorded using a Visual Analogue Scale (VAS) at 6, 12, 24, and 48 hours following treatment. The use of rescue analgesics will also be documented.
The study aims to determine which medication provides better pain relief and reduces the need for additional analgesics following endodontic treatment. Findings from this study may help guide clinicians in selecting the most effective medication for postoperative pain management in dental practice.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Post-endodontic pain is a frequently encountered complication following root canal therapy and may occur due to inflammatory responses caused by mechanical instrumentation, chemical irritation, or microbial factors affecting the periapical tissues. Effective pain management following endodontic procedures is important for improving patient comfort, treatment satisfaction, and recovery.
Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for dental pain because they inhibit cyclooxygenase enzymes responsible for prostaglandin synthesis, thereby reducing inflammation and pain. Among NSAIDs, diclofenac sodium and ibuprofen are widely used due to their analgesic and anti-inflammatory properties. However, differences in pharmacological action, tissue penetration, potency, and duration of effect may influence their comparative effectiveness in controlling post-endodontic pain.
This randomized controlled trial will be conducted at the Department of Operative Dentistry, Armed Forces Institute of Dentistry, Rawalpindi, Pakistan. A total of 60 participants aged 18-65 years diagnosed with irreversible pulpitis involving a single maxillary or mandibular first molar will be enrolled. Participants will be randomly allocated into two equal groups. One group will receive diclofenac sodium 50 mg, while the other group will receive ibuprofen 400 mg following completion of single-visit root canal therapy.
Standardized endodontic procedures will be performed by an experienced operator under local anesthesia using 2% lidocaine with epinephrine. Root canal preparation, irrigation, obturation, and temporary restoration will be completed using standardized techniques to minimize procedural variability.
Pain intensity will be assessed using a Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, and 48 hours after treatment. Participants will maintain a pain diary to record pain levels and rescue analgesic intake. Secondary outcomes include the frequency of rescue medication use and monitoring of adverse effects.
Data analysis will be performed using Statistical Package for Social Sciences (SPSS) version 23. Appropriate descriptive and inferential statistical methods will be applied following assessment of data normality. Comparative analysis between treatment groups will evaluate differences in postoperative pain scores and rescue analgesic requirements.
The results of this study may provide evidence regarding the comparative analgesic efficacy of diclofenac sodium and ibuprofen in endodontic pain management. This may support clinicians in selecting optimal postoperative analgesic protocols for patients undergoing root canal treatment.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
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Rawalpindi, Пакистан, 46000
- Armed Forces Institute of Dentistry
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
Patients diagnosed with Irreversible Pulpitis involving a single maxillary or mandibular first molar Age between 18 and 65 years Patients requiring single-visit root canal treatment Patients able to understand and record pain using Visual Analogue Scale (VAS) Systemically healthy individuals (ASA I-II) Willingness to participate and provide informed consent
Exclusion Criteria:
Pregnant or lactating women Presence of periapical pathology on radiographic examination Patients with generalized periodontal disease affecting prognosis Use of analgesics or anti-inflammatory drugs within 6 hours prior to treatment Known allergy to Ibuprofen, Diclofenac sodium, or other NSAIDs Patients on medications affecting pain perception (e.g., opioids, antidepressants, anticonvulsants) History of drug abuse or substance dependence Non-vital pulp detected during access opening or instrumentation Inability to complete endodontic treatment in a single visit Failure to achieve proper bleeding response confirming diagnosis of irreversible pulpitis
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Ibuprofen Group
Participants assigned to this arm will receive a single oral dose of 400 mg of Ibuprofen immediately after completion of single-visit root canal treatment.
Pain intensity will be recorded using the Visual Analogue Scale at 6, 12, 24, and 48 hours post-treatment.
Rescue analgesic intake will also be documented.
|
Participants assigned to this intervention will receive 400 mg oral ibuprofen immediately after completion of single-visit root canal treatment.
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) commonly used for postoperative pain management due to its analgesic and anti-inflammatory effects.
Pain intensity will be monitored using the Visual Analogue Scale at 6, 12, 24, and 48 hours after treatment.
Другие имена:
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Экспериментальный: Diclofenac Sodium Group
Participants assigned to this arm will receive a single oral dose of 50 mg of Diclofenac sodium immediately after completion of single-visit root canal treatment.
Pain intensity will be recorded using the Visual Analogue Scale at 6, 12, 24, and 48 hours post-treatment.
Rescue analgesic intake will also be documented.
|
Participants assigned to this intervention will receive 50 mg oral diclofenac sodium immediately after completion of single-visit root canal treatment.
Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties used for postoperative pain control.
Pain intensity will be assessed using the Visual Analogue Scale at 6, 12, 24, and 48 hours following treatment.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Postoperative Pain Intensity Following Root Canal Treatment
Временное ограничение: 6, 12, 24, and 48 hours after completion of root canal treatment
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Postoperative pain intensity will be assessed using a 10-point Visual Analogue Scale (VAS) to compare the analgesic effectiveness of Diclofenac sodium and Ibuprofen following single-visit root canal treatment.
Participants will record pain scores at predefined intervals after treatment.
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6, 12, 24, and 48 hours after completion of root canal treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Rescue Analgesic Consumption Following Root Canal Treatment
Временное ограничение: Within 48 hours after completion of root canal treatment
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The frequency and quantity of rescue analgesic intake will be recorded to evaluate additional pain medication requirements in participants receiving either diclofenac sodium or ibuprofen after endodontic treatment.
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Within 48 hours after completion of root canal treatment
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- AFID-OPER-PEP-2025-01
- IRB Approval Number (Другой идентификатор: TMU-JIRB N202410073)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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