Effect of a Herbal Intracanal Medication On Postoperative Pain And Flare up Incidence In Non Surgical Root Canal Retreatment

Официальное название

Effect Of Phytotherapeutics As Intracanal Medication On Postoperative Pain And Flare up Incidence In Non Surgical Root Canal Retreatment. (Randomized Clinical Trial)

Обзор

The primary objective of this randomized clinical trial is to evaluate and compare the effectiveness of two natural, herbal-based intracanal medications-Propolis and Green Tea Polyphenolics (EGCG)-against the conventional Calcium Hydroxide in reducing postoperative pain and the incidence of flare-ups during non-surgical root canal retreatment. Postoperative pain is a common complication in endodontics, particularly in retreatment cases where complex bacterial environments and procedural challenges increase the risk of discomfort and acute flare-ups. While Calcium Hydroxide is the traditional gold standard due to its antimicrobial properties, natural phytotherapeutics like Propolis and Green Tea are being investigated for their potent anti-inflammatory, antioxidant, and antibacterial benefits, which may offer superior biocompatibility and symptomatic relief. Forty patients requiring endodontic retreatment of single-rooted teeth will be randomly assigned to one of three groups: Group I (Control): Receives Calcium Hydroxide paste. Group II: Receives Propolis-based medication. Group III: Receives Green Tea Polyphenolic-based medication. The study follows a two-visit protocol. During the first visit, the previous root canal filling is removed, the canal is cleaned and shaped, and the assigned medication is placed. Postoperative pain will be assessed using a Visual Analog Scale (VAS) at 6, 12, 24, 48, 72 hours, and 7 days. Flare-up incidence (sudden severe pain or swelling) will also be monitored. In the second visit, the medication is removed, and the canal is permanently sealed using a bioceramic sealer and gutta-percha. The results will help determine if these herbal alternatives can provide a more comfortable treatment experience for patients undergoing root canal retreatment.

Вмешательства

• Препарат Calcium hydroxide
  Following chemo-mechanical preparation and canal drying, Calcium Hydroxide paste is inserted into the root canal using a specialized syringe. The material is placed 0.5-1 mm from the apex to ensure complete filling without extrusion. It remains in the canal until the second visit for obturation.
• Препарат Propolis Extract
  After cleaning, shaping, and drying the root canal, a Propolis-based natural resinous substance is used as an intracanal medication. The material is delivered via syringe to a depth of 0.5-1 mm from the apex. This herbal medicament is utilized for its antimicrobial and anti-inflammatory properties.
• Препарат Green Tea Polyphenolics (EGCG)
  Following the standardized cleaning protocol and canal drying, Green Tea Polyphenolics (EGCG) extract is inserted as an intracanal medication. The extract is placed 0.5-1 mm from the apex using a syringe. It serves as an herbal antioxidant and antimicrobial agent during the inter-appointment period.

Первичные конечные точки

• Postoperative pain [Срок оценки: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.]
• Flare-Up Incidence [Срок оценки: Within 7 days post-treatment]

Критерии участия

Критерии включения

• Failed previously performed endodontic treatment of single-rooted teeth.
• Presence of a periapical lesion ranging from 1 mm to 2 mm in diameter.
• Teeth with complete root formation.
• Teeth without evidence of external or internal root resorption.

Критерии исключения

• Pregnant females.
• Patients with uncontrolled systemic diseases.
• Patients currently under antibiotic or analgesic administration.
• Patients presenting with facial swelling.
• Teeth not indicated for endodontic retreatment (e.g., poor oral hygiene, mobile teeth, or recessed teeth).

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07578311 · EC-MU Research No.1254

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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