A Randomized Controlled Trial to Compare the Histomorphometric and Clinical Outcomes of Soft Tissue Augmentation at the Time of Lateral Ridge Augmentation Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm)
研究概览
简要总结
This study will compare two commonly used soft tissue grafting techniques (connective tissue graft, CTG vs Acellular Dermal Matrix, ADM) to augment the soft tissue at the time of lateral ridge augmentation procedure.
Following ridge augmentation procedure, most of the times there is a need for soft tissue augmentation to change the quality of the tissue around future implant's site. To our knowledge, the influence of soft tissue augmentation at the time of ridge augmentation procedure has not been tested defects.
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. Ridge augmentation procedure can alter the quality of tissue in the sites where it will receive dental implants. Soft tissue grating aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants. CTG or ADM will be grafted at the same time of lateral ridge augmentation procedure.
Specific aims for this project include the evaluation of:
- To evaluate the quality of soft tissue regenerated with the use of the two available soft tissue grafts via histological analysis.
- To evaluate whether CTG or ADM influences the outcomes of Guided Bone Regeneration (GBR) procedures.
- To quantify the soft tissue augmentation achieved by the two available soft tissue grafts by direct clinical measurements after the healing
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
- •Be a registered University of Alabama at Birmingham (UAB) dental school patient
- •English Speaking
- •Healthy enough to undergo the proposed therapy
- •Demonstrated willingness to comply with study directions and time-line
- •Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan.
- •Able to read and understand the informed consent form
- •Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth.
排除标准
- •No English Speaking
- •Smokers/ tobacco users (>10 cigarettes a day)
- •Less than 18 years old
- •Know hypersensitivity to titanium
- •Patients with significant medical conditions or habbits expected to interfere with bony healing.
- •Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)
- •Bone dehiscence of >4mm following tooth extraction or Vertical loss of bone at edentulous ridge
研究组 & 干预措施
connective tissue graft
Connective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft
干预措施: Connective tissue graft at time of bone graft (Procedure)
Acellular Dermal Matrix
Acellular Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft
干预措施: Acellular Demal Matrix at time of bone graft (Procedure)
No soft tissue graft (Control)
Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added.
干预措施: No soft tissue grafting at time of bone graft (Procedure)
结局指标
主要结局
Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm)
时间窗: From baseline to 6 months
The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe.
Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm)
时间窗: From baseline to 6 months
The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.
Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin
时间窗: From baseline to 6 months
The changes in clinical soft tissue thickness at 4mm apical form the gingival margin by using an endodontic file and periodontal probe.
Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin
时间窗: From baseline to 6 months
The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.
次要结局
未报告次要终点
研究者
Hussein Basma
Principal Investigator
University of Alabama at Birmingham