NCT06335628招募中不适用
Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Volumetric dimensional changes
研究概览
简要总结
The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent signed by the subject
- •Age ≥ 18 years
- •Willingness to sign informed consent and to participate in the study
- •Single tooth gap or extended edentulous space in the lower or posterior jaw including a pontic site with a soft tissue deficiency.
- •Tooth gap of ≥ 8 mm.
- •Presence of natural or artificial opposing dentition
- •Sufficient vertical interocclusal space of an implant restoration (7mm)
- •Bounded by natural and periodontally stable teeth
- •Treatment plan must include tooth replacement with an implant or tooth-supported fixed dental prosthesis.
排除标准
- •Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
- •Severe bruxism, clenching habits, or presence of oro-facial pain
- •Uncontrolled diabetes mellitus (HbA1c >7.0)
- •Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- •Any active oral or systemic acute infections
- •Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
- •Severe hematologic disorders
- •Any other diseases or medications that may compromise normal wound healing
- •Pregnancy or nursing mother
- •Contraindications and limitations of the MD as described in the instructions for use: during pregnancy or lactation, children, presence of acute infection in the surgical area, patients with known sensitivity to porcine material or collagen allergies.
- •Vulnerable subjects
- •Known or suspected non-compliance
- •Drug or alcohol abuse
- •Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc.
- •Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
- •Enrolment of the PI, his/her family members, employees and other dependent persons
研究组 & 干预措施
Group A: Connective Tissue Graft (CTG)
No Intervention
Volumetric changes between groups will be compared by matching intraoral scans before and after surgery (including follow-ups after 5 years) using the engineering software Geo-Magic®.
Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-Gide®
Experimental
The CTG (Group A) is the gold-standard for soft tissue augmentation, therefore it is considered the control group in this investigation.
干预措施: Geistlich Fibro-Gide® (Device)
结局指标
主要结局
Volumetric dimensional changes
时间窗: 0-5 years
To assess the volumetric dimensional changes in pontic sites after site development using CTG compared to VCMX
次要结局
- Clinical: PPD(0-5 years)
- Clinical BoP(0-5 years)
- Clinical: Thickness(0-5 years)
- Clinical: Contributing factors(0-5 years)
- Patient-reported satisfaction(0-5 years)
- Patient-reported esthetics(0-5 years)
- Clinical: Suppuration(0-5 years)
- Clinical: Mucosa(0-5 years)
- Clinical: ktw(0-5 years)
- Clinical: Mobility(0-5 years)
- Patient-reported discomfort(0-5 years)
- Patient-reported pain(0-5 years)
- Prosthetics Survival(0-5 years)
- Prosthetics Success(0-5 years)
- Prosthetics Complications(0-5 years)
- Prosthetics PES-WES(0-5 years)
- Prosthetics: Occlusal(0-5 years)
- Prosthetics: Interproximal(0-5 years)
- Radiographics BL(0-5 years)
- Radiographics PP(0-5 years)
- Radiographics distance(0-5 years)
- Radiographics Contacts(0-5 years)
研究者
研究点 (1)
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