The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament

Официальное название

The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament During Root Canal Treatment: A Randomized Clinical Trial

Обзор

The goal of this randomized clinical trial is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis. The main question\[s\] it aims to answer are: • Will the diclofenac sodium (NSAIDs) possess antimicrobial efficacy to be used effectively as an intracanal medicament similar to that of calcium hydroxide in primary endodontic treatment? Participants will be allocated randomly into three equal groups by using computer generated randomization, according to the type of intracanal medication.

Подробное описание

The aim of the present study is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis. The evaluation is to be done using quantitative microbiological assessment from samples extracted from root canals before and after intracanal medicament placement in roots of permanent molars, having PAI score ≥ 2.

Вмешательства

• Препарат Diclofenac Sodium
  placement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week.
• Препарат Calcium hydroxide
  placement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week.

Первичные конечные точки

• Bacterial count [Срок оценки: On the seventh day from of intracanal medication placement appointment]

Вторичные конечные точки (3)

• Periapical healing [Срок оценки: participants will be recalled after 6 months from the obturation for radiographic examination.]
• incidence and intensity of pain [Срок оценки: Pain intensity will be assessed at 24 hours, 48 hours and 72 hours following initial treatment using a visual analogue scale]
• Incidence of flare-ups [Срок оценки: Presence of flare-ups will be recorded each day after the intracanal medication placement visit till the next visit (after seven days).]

Критерии участия

Критерии включения

• Patients with teeth diagnosed with apical periodontitis
• Periapical Index (PAI) ≥ 2
• The teeth are restorable

Критерии исключения

• Teeth with immature roots
• Non restorable teeth
• Medically compromised patients with systemic complication that would alter the treatment.
• Teeth with internal/external root resorption
• Patient with an allergy to diclofenac sodium

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• British university in Egypt — Cairo

Идентификаторы

NCT: NCT06207253 · 23-039

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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