Clinical and Histological Analysis of Soft Tissue Volume Gain and Stability Around Dental Implants Using Autogenous Subepithelial Connective Tissue Grafts Harvested From the Palate or Tuberosity. A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 主要终点
- Soft tissue volume gain
研究概览
简要总结
The goal of this study is to compare clinical and histologically the soft tissue changes in terms of volume gain and stability around dental implants in cases where a subepithelial connective tissue graft from the palate or from the tuberosity is used randomly
详细描述
Understanding the importance of the soft tissue around implants have lead clinicians to develop surgical approaches to augment it. The majority of them, are described as bilaminar techniques obtaining a subephitelial connective tissue graft (SCTG) from the palate (P). However, recent studies have demonstrated that tuberosity (T) tissue is a very dense and coarse tissue that seems to contain more collagen and less fat and glandular tissue than that from the P, and therefore may have better tissue qualities for soft tissue augmentation, but there is limited scientific evidence comparing these areas.
The main goal of this study is to compare the soft tissue volume gain and stability around implants in cases where a SCTG of the same dimensions from the P or T is used randomly. To calculate volume changes and stability an intraoral optical scan is used and three-dimensional images superimposed.
The secondary goal is to compare histologically both tissues and changes in clinical parameters. Histomorphometry and immunohistochemistry evaluating levels of Type I-III collagen, long lysyl hydroxylase, matrix metalloproteinase 1-2, and monoclonal antibody against cytokeratin 4-10-13 is performed.
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)
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
- •Patient must be ≥18 years and able to understand the nature of the proposed surgery and to a signed informed consent.
- •Implant must be located between 2 fixed reference points i.e. clinical crowns.
- •All implants locations with a need of a soft tissue volume augmentation.
- •Palate must have ≥2mm of thickness at premolar area.
- •Tuberosity > 12mm in length.
- •Full mouth plaque and bleeding score <20%.
排除标准
- •Previous soft tissue augmentation in the area.
- •Heavy Smokers (> 10 cigarettes per day).
- •Local or systemic conditions that would interfere with routine periodontal therapy (non controlled diabetes, liver function disorder, immunosuppressant disease, autoimmune disease).
- •Allergy to Non-Steroidal Anti-Inflammatory Drugs.
- •Patients taking medications that cause gingival enlargement
- •Gingival idiopatic overgrowth
结局指标
主要结局
Soft tissue volume gain
时间窗: Baseline to 3 months postoperative
Following soft tissue augmentation procedure volume gain is registered using intraoral optical scan. Superposition between three dimensional images from baseline (before augmentation procedure) and 3 months postoperative is done.
Soft tissue stability
时间窗: 4 months postoperative to 12 months postoperative
To evaluate soft tissue stability an intraoral optical scan is performed at 4 and 12 months postoperative. Also a superimposition between 4 months and 12 months optical images is done.
次要结局
- Clinical periodontal parameters Plaque Index and Bleeding on probing(Baseline, 3 months, 4 months, 12 months)
- Histology(Baseline)
- Clinical periodontal parameters.Probing depth(Baseline, 3 months, 4 months, 12 months)
- Clinical periodontal parameters. Width of keratinized tissue(Baseline, 3 months, 4 months, 12 months)
研究者
Ernest Rojo Xicart
Professor Section of Periodontology
Universitat Internacional de Catalunya