The Tooth Collar Technique

Официальное название

The Tooth Collar Technique (TCT): a Prospective Case Series on a Novel Flap Design for Ridge Augmentation

Обзор

The aim of this study is to evaluate wound healing after the application of the Tooth Collar Technique (TCT) for bone augmentation in the upper or lower jaw. This technique is designed to promote tension-free wound closure and to reduce the risk of wound dehiscence. Augmentation is performed under local anesthesia. The gingiva is opened according to the TCT, after which the bone defect is reconstructed with standard biomaterials and covered with a membrane. No experimental materials are used- only a modified incision technique.

Подробное описание

The purpose of this study is to evaluate the clinical performance and feasibility of the Tooth Collar Technique, a novel flap design for horizontal and vertical bone augmentation, in terms of early wound healing and surgical outcomes. Published studies on horizontal and vertical bone augmentation report early wound dehiscence or exposure rates typically in the 15-30% range, with higher values for complex vertical procedures and non-resorbable barriers. Therefore, 20% is set as the Objective Performance Criterion for early wound dehiscence.

Вмешательства

• Процедура Tooth Collar Technique
  During surgery, the gingiva will be opened using tooth collar technique instead of standard flap designs; after which the bone defect is augmented using standard biomaterials and covered with a membrane.

Первичные конечные точки

• early wound dehiscence [Срок оценки: within 14 days after augmentation]
• Early Wound dehiscence [Срок оценки: within 14 days after augmentation]
• primary wound healing [Срок оценки: within 14 days after augmentation]
• Early Wound dehiscence [Срок оценки: within 14 days after augmentation]

Вторичные конечные точки (7)

• soft tissue healing quality [Срок оценки: day 7, 14, 30 and 120 after augmentation]
• Need for -re-intervantions [Срок оценки: within 30 days after augmentation]
• incidence of post-operative infection [Срок оценки: within 30 days after augmentation]
• Gingival condition [Срок оценки: at 4 months after augmentation]
• Procedural parameters: closure tension [Срок оценки: immediately after surgery]
• Procedural parameters: Periosteal release length [Срок оценки: Immediately after surgery]
• Procedural parameters: surgical time [Срок оценки: Intraoperative]

Критерии участия

Критерии включения

• Voluntary written informed consent of the participant or their legal authorized representative has been obtained prior to any screening procedures
• At least 18 years of age at the time of signing the Informed Consent Form (ICF)
• Indication for horizontal and/or vertical bone augmentation in the maxilla or mandible in preparation for implant placement
• Sufficient general health to undergo elective oral surgical procedures, as judgjed by the investigator
• Ability and willingness to attend all study visits and comply with the protocol requirements.

Критерии исключения

• Current smoking or use of other nicotine-containing products (eg, e-cigarettes, chewing tobacco)
• Presence of uncontrolled systemic diseases that may compromise healing
• Ongoing chemotherapy, radiotherapy, or bisposphonate/anti-resorptive therapy in the head or neck region
• History of radiation therapy to the jaws
• active or untreated periodontal disease, caries or poor oral hygiene
• Poorly fitting restorations on teeth adjacent to the augmentation site
• Known allergy or hypersensitivity to any material used in the augmentation procedure.
• Pregnant or breastfeeding women, or women planning pregnancy during the study period.
• Participation in another interventional clinical study within the last 30 days
• Any other condition or circumstance that, in the opinion of the investigator, could compromise participant safety, compliance, or the validity of the study results.
• Participation in an interventional study with an investigational medicinal product or device.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 4 центра

• ParoPlus Aalst — Aalst
• Radix Dental — Heist-op-den-Berg
• Parodontologie & Implantologie Merchtem — Merchtem
• UZ Leuven — Leuven

Идентификаторы

NCT: NCT07753525 · S71663

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗