Phenotype Modification Via Guided Bone Regeneration and Acellular Dermal Matrix Simultaneous to Delayed Implant Placement: A Double Arm Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Horizontal linear change of the buccal bone
研究概览
简要总结
Single implant sites with bone loss can often be managed by bone grafting alone. The purpose of this study is to determine whether putting a soft tissue graft substitute over the bone graft will provide an increased benefit for improving the health, appearance, and stability of the bone and gums surrounding the implant.
详细描述
The study will treat patients that need a single implant at a previously edentulous site (>3 months post extraction) that requires phenotypic modification. These patients will receive an implant with simultaneous GBR, with half of the participants also receiving an ADM graft.
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 (Participant, 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
- •Age ≥ 18 years.
- •Subjects with a physical status of systemically healthy or suffering from mild to moderate, but well-controlled disease; American Society of Anesthesiology (ASA) I or II.
- •Subjects must have one edentulous region, with at least 3 months of healing post-extraction, in the esthetic zone of the maxilla or the premolar and canine region of the mandible. This region includes the maxillary premolars, canines, and incisors.
- •Subjects must have a full mouth plaque and bleeding score of less than or equal to 20%, measured at four sites per tooth.
- •The patients should have a thin periodontal phenotype; bucco-lingual ridge thickness greater than 6mm.
- •Seibert class I deficiency (Seibert, 1983)
- •Patients willing to sign the informed consent.
排除标准
- •Presence of uncontrolled and/or untreated periodontal disease.
- •Patients currently smoking cigarettes, cannabis, and electronic cigarettes.
- •Subjects taking medications known to impact bone metabolism or have the capacity to affect wound healing. These drugs include bisphosphonates, corticosteroids, parathyroid hormone, RANKL inhibitors, past exposure to head and neck radiation, chemotherapy within the last 12 months, among others.
- •Subjects with systemic diseases that impact bone metabolism and wound healing. Namely, osteoporosis, osteopenia, hyperparathyroidism, Paget's disease.
- •Allergy to the graft materials.
- •Pregnant subjects or individuals who self-report as attempting to become pregnant.
- •Patient's unwilling to sign the informed consent.
研究组 & 干预措施
Guided bone regeneration
Guided bone regeneration with collagen membrane
干预措施: Dental implant placement (Procedure)
Guided bone regeneration
Guided bone regeneration with collagen membrane
干预措施: Guided bone regeneration with collagen membrane (Procedure)
Guided bone regeneration with Phenotype modification.
Guided bone regeneration with an allogenic dermal matrix
干预措施: Dental implant placement (Procedure)
Guided bone regeneration with Phenotype modification.
Guided bone regeneration with an allogenic dermal matrix
干预措施: Guided bone regeneration with acellular dermal matrix. (Procedure)
结局指标
主要结局
Horizontal linear change of the buccal bone
时间窗: 6 months
Radiographic changes of bone level in mm based on cone-beam computed tomography
次要结局
- The volumetric changes of the facial soft tissue(6 months)
- Histological bone density(6 months)
- The vascular changes of the facial soft tissue(6 months)
- Peri-implant health, as defined by clinical attachment level.(6 months)
- Patient-reported morbidity, satisfaction and comfort using a visual analogue scale (VAS)(6 months)
- Clinician-reported overall treatment effectiveness(6 months)
研究者
Muhammad Saleh
Clinical Assistant Professor of Dentistry, Department of Periodotnics and Oral Medicine, School of Dentistry
University of Michigan