Randomized Controlled Clinical Study to Investigate Effectiveness and Safety of a Collagen Matrix 10808 for Soft Tissue Volume Augmentation After Implant Placement in Single Tooth Gaps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing
研究概览
简要总结
The objective of this study is to investigate the safety and the function of the collagen Matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of the autologous connective tissue graft. The Collagen Matrix was developed for soft tissue augmentation. It is a three dimensional porous Matrix and consists mainly of Collagen I and III.
Study patients must have a single tooth gap with insufficient soft tissue volume after implant placement. Therefore a soft tissue augmentation will be necessary.
详细描述
The primary objective of this study is to assess the effectiveness of soft tissue volume augmentation procedures using the autogenous soft tissue graft or the Collagen Matrix 10808 to gain mucosal thickness. Second the safety of the two procedures will be investigated.
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
- Single (Outcomes Assessor)
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
- •Implant placement at least 6 weeks and maximum 6 months prior enrolment
- •Necessity of soft tissue augmentation in single tooth gap
- •2 teeth adjacent to each side of the defect have a mean BOP (Bleeding of probing) of < 30%
- •Basic periodontal examination (BPE <2)
- •18 years or older
- •Ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
- •Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form
排除标准
- •Heavy smoker (> 10 cigarettes per day)
- •Probing depth greater than 4 mm
- •Insulin dependent diabetes
- •General contraindications for dental and/or surgical treatment
- •History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
- •Women of child bearing age, not using a standard accepted method of birth control
- •Pregnancy or breast feeding
- •Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
- •Disease affecting connective tissue metabolism (e.g. collagenases).
- •Allergy to collagen
- •Participation in a clinical trial within the last six months
研究组 & 干预措施
Collagen Matrix 10808
Mucosal split-thickness flap in combination with the Collagen Matrix 10808.
干预措施: Collagen Matrix 10808 (Device)
Connective tissue graft (gold standard)
Mucosal split-thickness flap in combination with the connective tissue graft.
干预措施: Connective tissue graft (Procedure)
结局指标
主要结局
Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing
时间窗: at day 90 compared to day 0 (Baseline)
次要结局
- Probing Depth (mm)(at day 0 and at day 90)
- Plaque Index (0-3)(at day 0 and at day 90)
- Closure of the wound(at Day 7, 30, 90)
- Qualitative histological assessment regarding matrix degradation and safety parameters(at day 90)
- Gain in mucosal soft tissue thickness by 3D volumetric analysis(at day 90, compared to day 0)
- Assessment of Adverse Events(from Day 0 to Day 90)
- Presence of Swelling(at Day 7, 30, 90)
- Surgery time(at surgery)
- Keratinized Tissue width (mm)(at day 0 and at day 90)
- Bleeding of Probing (0/1)(at day 0 and at day 90)
- Oral health impact profile (OHIP-G14) score(at day 0, 7, 90)
- Gain in mucosal soft tissue thickness measured by trans-mucosal probing(at day 30 compared to day 0)
- Recession depth (mm)(at day 0 and at day 90)
- Daily Mefenaminacid consumption(between Day 0 and Day 7)
- Evaluation of pain using a VAS(Visual Analogue Scale) score daily(between Day 0 and day 7 and at Day 30 and 90)
- Clinical Attachment Level (mm)(at day 0 and at day 90)