The Tooth Collar Technique (TCT): a Prospective Case Series on a Novel Flap Design for Ridge Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- early wound dehiscence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tooth Collar Technique
Participants of the study will receive surgery using the Tooth Collar Technique prior to ridge augmentation.
干预措施: Tooth Collar Technique (Procedure)
结局指标
主要结局
early wound dehiscence
时间窗: within 14 days after augmentation
Incidence of early wound dehiscence (yes/no) at the crest of the surgical site
Early Wound dehiscence
时间窗: within 14 days after augmentation
Documentation of location of wound dehiscence (if there is wound dehiscence) with clinical photo
primary wound healing
时间窗: within 14 days after augmentation
quality of primary wound healing using Wound Healing Index (WHI) of PMID16253095 ( score 1 = uneventful healing with nogingival edema, erythema, suppuration, patient dis-comfort, or flap dehiscence; score 2 = uneventfulhealing with slight gingival edema, erythema, patientdiscomfort, or flap dehiscence, but no suppuration;and score 3 = poor wound healing with significantgingival edema, erythema, patient discomfort, flapdehiscence, or any suppuration.)
次要结局
- Gingival condition(at 4 months after augmentation)
- soft tissue healing quality(day 7, 14, 30 and 120 after augmentation)
- Need for -re-intervantions(within 30 days after augmentation)
- incidence of post-operative infection(within 30 days after augmentation)
- Procedural parameters: closure tension(immediately after surgery)
- Procedural parameters: Periosteal release length(Immediately after surgery)
- Procedural parameters: surgical time(Intraoperative)