Идёт набор NCT05813236

NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery

Без фазы С лечением Gingivitis Gingival Diseases Periodontal Diseases

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: Novosyn® in resective periodontal surgery, Monosyn® in resective periodontal surgery.
Кому может быть актуально: Состояния в реестре: Gingivitis, Gingival Diseases, Periodontal Diseases. Базовые параметры: от 18 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: Испания
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

Randomized, Monocentric, Double Blinded, Prospective Study to Evaluate the Early Wound Healing After the Utilization of NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery

Обзор

The aim of this study is to prove that Novosyn Quick and Monosyn Quick are equivalent in early wound healing in adult patients undergoing resective periodontal surgery. In order to show equivalence between Novosyn Quick and Monosyn Quick EHS, which is composed of 3 parameters: clinical signs of reepithelization, clinical signs of haemostasis and clinical signs of inflammation, will be calculated for each suture 10 ± 5 days postoperatively and cannot differ more than 2 points. Furthermore, complications, the handling of the suture material, pain, satisfaction of the patient and bacterial contamination of the thread (optional) will also be assessed as secondary objectives.

Вмешательства

Устройство Novosyn® in resective periodontal surgery
The aim of resective procedures is the re-establishment of a healthy periodontium at a reduced level, accepting as irreversible the destruction that has already occurred. In essence, these procedures are all designed to achieve pocket elimination or reduction by the apical shift of the gingival margin.
Устройство Monosyn® in resective periodontal surgery
The aim of resective procedures is the re-establishment of a healthy periodontium at a reduced level, accepting as irreversible the destruction that has already occurred. In essence, these procedures are all designed to achieve pocket elimination or reduction by the apical shift of the gingival margin.

Первичные конечные точки

early wound healing score (EHS) [Срок оценки: 10 ± 5 days postoperatively]

Вторичные конечные точки (12)

Number of patients showing postoperative wound dehiscence [Срок оценки: 10 ± 5 days postoperatively]
Number of patients showing postoperative Dentinal hypersensitivity [Срок оценки: 10 ± 5 days postoperatively]
Number of patients showing postoperative Oral candidiasis [Срок оценки: 10 ± 5 days postoperatively]
Number of patients showing postoperative Angular cheilitis [Срок оценки: 10 ± 5 days postoperatively]
Number of patients showing postoperative Swelling [Срок оценки: 10 ± 5 days postoperatively]
Number of patients showing postoperative Bleeding [Срок оценки: 10 ± 5 days postoperatively]
Number of patients showing postoperative Infection [Срок оценки: 10 ± 5 days postoperatively]
Number of Systemic complications [Срок оценки: 10 ± 5 days postoperatively]
Pain assessment [Срок оценки: 10 ± 5 days postoperatively]
Satisfaction of the patient [Срок оценки: 10 ± 5 days postoperatively]
Number of patients with Bacterial contamination of the thread (optional) [Срок оценки: 10 ± 5 days postoperatively]
Assessment of the handling of the suture material [Срок оценки: intraoperatively]

Критерии участия

Критерии включения

Adult patient undergoing resective periodontal surgery abd one of the incisions below has been performed:
Crestal incision
Vertical incision
Intrasulcular incision
Submarginal incision
Written informed consent regarding the data collection for the RCT