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Идёт набор NCT07555366

Post-Extraction Healing: microRepair vs Chlorhexidine

Без фазы С лечением Endodontic Issue Periodontal Issues

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: microRepair ABX Mousse, CHX mouthwash 0.20%.
Кому может быть актуально
Состояния в реестре: Endodontic Issue, Periodontal Issues. Базовые параметры: 18 лет — 75 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
Италия
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

Evaluation of Healing in Post-Extraction Sockets Using microRepair Abx Mousse Mouthwash Versus 0.20% Chlorhexidine

Обзор

This randomized clinical trial evaluates the efficacy of a microRepair ABX mouthwash mousse compared to 0.20% chlorhexidine in promoting wound healing following tooth extraction. The study monitors clinical parameters such as pain, swelling, and healing indices at 1, 7, and 15 days post-surgery. The primary objective is to determine if the microRepair ABX technology enhances tissue regeneration and reduces post-operative complications.

Подробное описание

The study aims to prospectively analyze the clinical action of two different topical agents on post-surgical wounds: a mousse containing biomimetic microparticles (microRepair ABX) and a standard 0.20% chlorhexidine liquid mouthwash. Patients scheduled for extraction due to endodontic or periodontal issues will be randomized into two treatment groups. The protocol includes a baseline assessment (T0) and subsequent clinical evaluations at 24 hours (T1), 7 days (T2), and 15 days (T3). Primary endpoints consist of plaque presence on the surgical wound, gingival texture, and pain levels measured via the Visual Analogue Scale (VAS). Secondary endpoints include swelling (edema), odor, tooth or prosthesis pigmentation, and oral health-related quality of life (OHIP-14). Wound healing progress is objectively quantified using the Clinical Healing Index (CHI), which assesses seven parameters: redness, edema, bleeding, pain on palpation, suppuration, granulation tissue, and the degree of epithelialization. Additionally, the study evaluates patient satisfaction and the "pleasantness" of the assigned product, while recording any adverse events or sensitivities during home application.

Вмешательства

  • Другое microRepair ABX Mousse
    Topical application of the mousse on the surgical wound starting from the day after the extraction. The mousse is specifically formulated to promote healing through microparticles that accelerate tissue repair and an antibacterial complex to prevent localized infections.
  • Другое CHX mouthwash 0.20%
    Application of 0.20% Chlorhexidine liquid mouthwash. Used as a control treatment to evaluate the comparative effectiveness of the test product in reducing plaque, pain, and inflammation while promoting socket healing.

Первичные конечные точки

  • Plaque Index at the Tooth Extraction Site [Срок оценки: From enrollment to the end of treatment at 15 days]
  • Gingival Condition of the Peri-Alveolar Tissue [Срок оценки: From enrollment to the end of treatment at 15 days]
Вторичные конечные точки (1)
  • Patient Satisfaction with the Product [Срок оценки: At 15 days post-treatment]

Критерии участия

Критерии включения

Age range: Patients between 18 and 75 years of age.

Indication for tooth extraction: Specifically for cases involving:

  • Destructive caries that do not allow for conservative or prosthetic recovery.
  • Untreatable endodontic and/or periapical lesions.
  • Advanced periodontal lesions with significant loss of supporting tissue.
  • Traumatic lesions involving root fractures (vertical or at the middle third).
  • Malpositioned teeth causing functional alterations.
  • Roots that cannot be prosthetically recovered or residual roots.

Критерии исключения

Age: Patients under 18 or over 75 years of age. Systemic Conditions: Presence of immunodepression or immunocompromisation (e.g., HIV infection).

Pregnancy and Lactation: Women who are currently pregnant or breastfeeding. Mental Health: Presence of psychiatric disorders. Tobacco Use: Severe smokers, defined as consuming more than 10 cigarettes per day.

Substance Abuse: History of alcohol or drug abuse.

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
Открытое
Основная цель
Лечение

Центры проведения

Италия · 1 центр
  • Sapienza università di Roma — Roma

Публикации

  • Sridhar V, Wali GG, Shyla HN. Evaluation of the perioperative use of 0.2% chlorhexidine gluconate for the prevention of alveolar osteitis after the extraction of impacted mandibular third molars: a clinical study. J Maxillofac Oral Surg. 2011 Jun;10(2):101-11. doi: 10.1007/s12663-011-0206-0. Epub 2011 Apr 22. PMID 22654359

Идентификаторы

NCT: NCT07555366 · 1957/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗