Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants

Официальное название

Comparative Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants -Randomized Controlled Trial.

Обзор

Comparative evaluation of cross-linked collagen membrane with and without silk fibroin around Immediate Dental Implants -Randomized controlled trial.

Подробное описание

Periodontal disease is an inflammatory and infectious disease affecting the tooth supporting structures leading to tooth loss when left untreated.The detrimental effect of periodontitis results in soft tissue and hard tissue loss. Bone defects has often resulted from tumor resection, congenital malformation, trauma, fractures, surgery, periodontitis or around implants in dentistry, as well as from diseases, such as osteoporosis or arthritis.These deficiencies have been overcome through various treatment modalities.It is a well-established fact that the cells from the periodontal ligament have the potential for regeneration of the tooth attachment apparatus. In addition, bone grafts and membranes have been used to regenerate the lost bone.

Among the membranes, autogenous connective tissue graft remains as gold standard. Collagen is biocompatible natural polymer that has a good function to promote new tissue formation. In the proposed study, immediate implants with compromised bone support, cross-linked bovine collagen membrane will be used. It is a naturally occurring protein, having excellent biocompatibility, and hemostatic and chemotactic characteristics for gingival fibroblasts and periodontal ligaments. Further, it is resistant to tension, controllable biodegradability, is non cytotoxic, low antigenicity, and excellent anti-inflammatory characteristics. It is naturally reabsorbed by microorganisms, easy to manipulate and has a molecular structure with little variance concerning the animal from which the collagen is extracted, leading to improved immunogenicity.

Bovine collagen is selected to enhance the biological function of silk fibroin, as composite membrane for enhancement of gingival thickness. Thus, considering all these characteristics, silk fibroin is incorporated into collagen membrane for evaluation .As there is no literature assessing this composite membrane, the aim of this study Compare evaluation of Cross-linked collagen membrane with and without Silk fibroin around Immediate Dental Implants Randomized controlled trial will be undertaken.

Вмешательства

• Другое collagen with silk fibroin membrane
  A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol. An immediate implant with collagen membrane ( comparative group) will be placed according to the standard protocol . The surgical wound closure will be coapted with mattress and single interrupted sutures
• Другое cross linked collagen membrane
  A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.

Первичные конечные точки

• To assess wound healing, gingival thickness and keratinized tissue width [Срок оценки: pre implant placement , 6 weeks , 12 weeks]

Вторичные конечные точки (1)

• Radiovisiography with grid [Срок оценки: pre implant placement , 6 weeks , 12 weeks]

Критерии участия

Критерии включения

• Systemically healthy patients in the age group of 18 to 55years.
• Patients undergoing immediate implant placement with gingival thickness ≤ 1mm
• Stage II /Stage III and Grade B Periodontitis patients.
• Radiographic assessment using Radiovisiography (RVG) with grid.

Критерии исключения

• Patients having allergies with collagen and silk products.
• Medical conditions contraindicating surgical interventions.
• Known smokers and alcoholic.
• Acute infections at the site of extraction. Ex Abscess.
• Patients who have undergone radiotherapy or chemotherapy.

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

Индия · 1 центр

• Krishnadevaraya college of dental sciences — Bangalore

Публикации

• Pripatnanont P, Chankum C, Meesane J, Thonglam J. Physical and biological performances of a semi-resorbable barrier membrane based on silk fibroin-glycerol-fish collagen material for guided bone regeneration. J Biomater Appl. 2021 Nov;36(5):930-942. doi: 10.1177/08853282211025781. Epub 2021 Jun 21. PMID 34152233

Идентификаторы

NCT: NCT06552065 · 02-D012-00050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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