A Prospective Randomized Clinical Trial to Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- The Increase in Keratinized Mucosa (in mm) Between the Two Grafts
研究概览
简要总结
This study will compare two commonly used soft tissue grafting techniques (free gingival graft, FGG vs. connective tissue graft, CTG) to augment the soft tissue around dental implants with a lack of keratinized mucosa.
To investigators knowledge, these 2 types of grafts have not been compared for differences in clinical (amount of KM increase, tissue thickness increase and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.
详细描述
Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Soft tissue grating (with FGG or CTG) aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants in question. While FGG is typically associated with higher postoperative discomfort than CTG, it has also been considered the gold standard in the treatment of these clinical conditions.
Specific aims for this project include the evaluation of:
- KM width at 6 and 12 months following grafting with FGG and CTG
- Change in tissue thickness of the grafted sites at 6 and 12 months
- Esthetic outcomes using a newly developed peri-implant esthetic scale at 6 and 12 month
- Patient centered outcomes including pain, bleeding, swelling and change in daily activities at 1 week for both groups and at 1 month for the CTG group
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •At least 18 years old
- •Must be a patient of the UAB Dental School, able to read and understand informed consent document
- •One or more adjacent dental implants having <2mm in width of keratinized mucosa or attached mucosa <1mm around their buccal aspect Contra-lateral or opposing implant sites with above criteria may be included and randomly assigned to soft tissue graft type
- •No crestal bone loss or minimal bone resorption not extending apical to first implant thread
- •Presence of periodontally healthy neighboring teeth, healthy implants or edentulous ridge on either side of the involved site (s)
- •Implants requiring soft tissue grafting after placement (>2 months): implants with healing abutments awaiting restoration or after delivery of temporary/permanent restoration
排除标准
- •Non-English speaking
- •Less than 18 years old
- •Smokers/tobacco users (>10 cigarettes/day)
- •Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- •Presence of peri-implantitis, acute infection and/or suppuration at the implant placement site (s)
- •Presence of soft tissue recession exposing threads at implant site
- •Presence of bony dehiscence at implant site (s)_ at time of surgery
- •Previous soft tissue grafting at the implant site (s)
结局指标
主要结局
The Increase in Keratinized Mucosa (in mm) Between the Two Grafts
时间窗: From baseline to 12 months
Compare the increase in keratinized mucosa (KM) between two commonly used soft tissue grafting techniques (FGG and CTG) by quantifying KM widths (in mm) at 12 months following soft tissue grafting.
次要结局
- Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG(From baseline to 12 months)
- Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG(From baseline to 12 months)
研究者
Ramzi V. Abou-Arraj
Principal Investigator
University of Alabama at Birmingham