Efficacy of Collagen Sponge Versus Collagen Membrane on Ridge Preservation of Periodontally Compromised Teeth

Официальное название

Efficacy of Collagen Sponge Versus Collagen Membrane in Combination With Collagenated Bovine Bone Mineral on Ridge Preservation of Compromised Extraction Sockets in Periodontitis Patients: a Randomized Controlled Clinical Trial

Обзор

The study aims to evaluate the efficacy of ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth.

Подробное описание

The study aims to evaluate the changes of clinical and radiographic outcomes following ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth. The included patients will be randomized into two groups. The patients in control group will be treated with collagen membrane + collagenated bovine bone mineral, and those in the test group will be treated with collagen sponge + collagenated bovine bone mineral. The horizontal width of ridge, the vertical height of ridge at the buccal and palatal/lingual plates, width of keratinized tissue and thickness of mucosa will be measured before surgery and at 6 months postoperatively.

Вмешательства

• Процедура alveolar ridge preservation
  Alveolar ridge preservation and augmentation commonly are performed immediately after tooth extraction to preserve or increase ridge volume within or beyond the skeletal envelope that exists at the time of extraction.

Первичные конечные точки

• change from baseline horizontal width of ridge at 6 months [Срок оценки: baseline, at 6 months]
• change from baseline vertical height of ridge at 6 months [Срок оценки: baseline, at 6 months]

Вторичные конечные точки (3)

• width of keratinized tissue [Срок оценки: at 6 months]
• thickness of mucosa [Срок оценки: at 6 months]
• postoperative pain [Срок оценки: at 2 weeks]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Need for molar extraction due to periodontal disease and plan for late implantation
• No acute infection, such as abscess or effusion
• Presence of bone defects on at one or two socket walls, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is >50% of the corresponding root length and the bone height of socket walls is at least 3 mm
• Presence of one adjacent tooth to the extraction site

Критерии исключения

• Smoking
• Pregnancy or lactation
• Untreated periodontal disease
• Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.)
• Under radiotherapy
• Systemic disease or medication that influences bone metabolism and mucosal healing (such as immunosuppressants, phenytoin, bisphosphonates etc.)
• Extraction of multiple adjacent teeth
• Allergy to any of the materials used in the study

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Affiliated Stomatology Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT05188196 · DHZhejiangU-2021（77）

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗