Идёт набор NCT07641933

Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases

Фаза I С лечением Intervention Studies ASA Physical Status I Intracanal Medication Periapical Abscess

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Calcium Silicate Intracanal Medication, Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal Medication, Calcium Hydroxide (Ca(OH)2) Intracanal Medication.
Кому может быть актуально: Состояния в реестре: Intervention Studies, ASA Physical Status I, Intracanal Medication, Periapical Abscess. Базовые параметры: 21 лет — 45 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases: A Randomized Controlled Clinical Trial

Обзор

The aim of this clinical trial is to evaluate anti-inflammatory effect of various intracanal medications: 1. Calcium Hydroxide Slurry mixed with 3% Sodium Hypochlorite 2. Calcium Silicate 3. Calcium Hydroxide In retreatment cases in terms of: 1. Biological Evaluation: Biomarker (IL 1B) 2. Radiographic Evaluation: CBCT 3. Clinical Evaluation: Pain Score (VAS)

Подробное описание

Sixty patients presenting with failed root canal treated lower first molars with periapical lesion were included in this randomized controlled single-center clinical superiority trial with two parallel arms and randomly allocated to 3 equal groups (n = 20) according to the type of ICM used. Patients were randomly allocated to receive either Ca(OH)2 slurry that was prepared from pure Ca(OH)2 powder mixed with 3% NaOCl, calcium-silicate (Bio-C Temp) or calcium hydroxide (CH) as ICM. Teeth were instrumented using a rotary file system (M3 pro Gold) and irrigated with 3% NaOCl. Subsequently, the root canals were dressed with a Ca(OH)2 + NaOCl or calcium silicate (test groups) or Ca(OH)2 (control group). Periapical fluid samples were collected after accessing the root canal in the first visit and after the root canal dressing removal in the second visit 2 weeks later using paper point. Samples were transferred to the microbiology lab immediately and levels of pro-inflammatory marker (IL1B) were measured using a specific enzyme-linked immunosorbent assay (ELISA) immediately after the second visit to test the reduction in inflammatory marker level after intracanal medication usage. Also, preoperative and 12 months-postoperative radiographic evaluation by CBCT were obtained to measure volumetric reduction in lesion size using segmentation technique. And patients rated their pain pre-operatively and then after 6, 12, 24, 48, 72 h and 7 days using the VAS score. Clinical and radiographic follow-up evaluations were scheduled for 1 week, 1 month, 6 months and 12 months by examining the patient clinically using palpation and percussion tests and pain questionnaire and periapical digital radiographs to compare reduction in lesion size.

Вмешательства

Препарат Calcium Silicate Intracanal Medication
Calcium silicate-based bioceramic materials have gained attention for their bioactivity and biocompatibility, acting through hydration with calcium hydroxide release followed by hydroxyapatite formation that promotes healing. Bio-C Temp is an example, characterized by high calcium ion release, alkaline pH, adequate radiopacity, and good biocompatibility.
Препарат Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal Medication
Combining calcium hydroxide with sodium hypochlorite (NaOCl) has been proposed. NaOCl provides rapid and potent antimicrobial and tissue-dissolving effects, while Ca(OH)₂ offers prolonged action. Both agents retain their properties when combined, and this combination may produce a synergistic effect that enhances disinfection and reduces chair time in two-visit treatment protocols.
Препарат Calcium Hydroxide (Ca(OH)2) Intracanal Medication
Calcium hydroxide ICM being the most widely used due to its high alkalinity, antimicrobial properties, endotoxin neutralization, and ability to reduce periapical inflammation. It is applied as an aqueous mixture or polyethylene glycol-based paste and provides a slow but sustained antimicrobial effect. Despite their benefits, Ca(OH)₂ medicaments re limited by their solubility, susceptibility to tissue fluids, potential to weaken tooth structure over time, and reduced effectiveness against resista

Первичные конечные точки

Biological Evaluation of inflammatory marker (IL-1B) [Срок оценки: 1st sample is collected in the first visit after root canal filling removal while 2nd sample is collected after intracanal medication removal in the second visit. Both visits are 14 days apart.]

Вторичные конечные точки (1)

Radiographic Evaluation using limited FOV CBCT [Срок оценки: 1 year between pre- and post-operative CBCT scans.]

Критерии участия

Критерии включения

Age: 21-45 years.
Medically free patients. (ASA Class 1)
Gender: males and females
Patients who are cooperative at operation and in attendance at scheduled follow-up visits.
Restorable root canal treated permanent lower first molars with periapical lesions.
Small (<5 mm) or medium periapical lesion size (5-10 mm)