Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft for Soft Tissue Augmentation At Implant Site. a Comparative, Multicentre Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- GT
研究概览
简要总结
Recent data suggested that an adequate volume of Keratinized Tissue (KT) around dental implant is a key factor to obtain aesthetic outcomes and to support easy long-term maintenance.
The aim of this RCT is to test the volume-stable collagen matrix (VCMX) vs the Connective Tissue Graft (CTG) for peri-implant soft tissue augmentation during implant uncovering.
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 (Investigator, Outcomes Assessor)
盲法说明
Examiners will be blinded throughout all experimental procedures for all measurements.
Operators will be blinded until they will raise the flap and screw the healing abutment.
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
- •Age ≥18 years.
- •No systemic diseases or pregnancy.
- •Self-reported smoking ≤10 cigarettes/day.
- •No probing depths ≥5 mm
- •Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤15% (measured at four sites per tooth).
- •Single dental implant with a scheduled for soft tissue augmentation procedure at the time of uncovering.
- •Need of soft tissue augmentation for aesthetic purpose and/or functional reasons
- •No previous soft tissue augmentation procedure at experimental site.
排除标准
- •General contraindications for dental and/or surgical treatments
- •Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy
- •Inflammatory and autoimmune disease of oral cavity
- •History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years
- •Radiotherapy of head area
- •Disease or condition affecting connective tissue metabolism (e.g. disease of arteries in the operating zone, bone metabolic diseases, alcohol abuse, treatment with anticoagulants)
- •Any systemic diseases that affect bone metabolism (e.g thyroid dysfunction, autoimmune disease)
- •Untreated acute periodontal disease
- •Patients who smoke more than 10 cigarettes/day will be excluded from the study
- •Allergy to the collagen
- •Pregnant or lactating women
- •Women of child bearing age, not using a highly effective method of birth control
- •Participation in an investigational device, drug or biologic study within the last 24 weeks prior to the study start
结局指标
主要结局
GT
时间窗: 12 months after surgery
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
次要结局
- PROMs(12 months after surgery)
- KT(12 months after surgery)
研究者
Dr. Francesco Cairo
Prof.
University of Florence