A Randomized Control Trial Testing Connective Tissue Grafts vs. Allograft on Dental Implants
Implant Associated Soft Tissue Defects in the Anterior Maxilla: A Randomized Control Trial Between Subepithelial Connective Tissue Graft and Acellular Dermal Matrix Allograft
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy adults of at least 18 years of age
- Maxillary non-molar implant with failing pink esthetic profile
- Implants with adjacent landmarks (only one can be an implant)
- Healthy implants measured by the lack of peri-implantitis and mucositis
- Good oral hygiene.
Exclusion Criteria:
- Unstable systemic diseases, compromised immune system, or unstable bleeding disorders
- History of radiation or cancer in the oral cavity
- Use of IV bisphosphonate or steroid medication
- Use of tobacco products (>1/2 pack per day)
- Pregnancy
- Mucogingival surgery or implant placement within the past six months
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Connective Tissue Graft - Control
The donor tissue was harvested from tissue palatal to maxillary premolars and anterior to the mesial of the first molars.
A horizontal incision corresponding to the width of the recipient bed plus 4mm was made 3 mm apical to the gingival margin.
A small secondary vertical incision was tolerated on the mesial aspect of the surgical site to allow for a split thickness technique.
The flap was then positioned over the graft and sutured with attempts to cover the grafted tissue to 2mm coronal to the implant/abutment interface pending flap tension.
Follow up was monitored over 6 months at various time-points.
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All patients were treated with infiltration of local anesthetic with vasoconstrictor if noted tolerable by the medical history. Surgeons were then notified if the patient was randomized to the test or control according to a blinded treatment assignment. In both groups, anesthesia was confirmed at the implant site and the palatal donor site if indicated. The recipient bed was then prepared. Vertical incisions were made at the defect at line angles and horizontal incisions connected the two vertical releases intrasulcularly without involving the interdental papilla. The flap was reflected as a full thickness flap maintaining the integrity of the collagen attachment with de-epithelialization of papilla to allow for coronal advancement. |
实验性的:Alloderm - Test
ADM graft was prepared according to the manufacturer's instructions.
The preparation requires rehydration in 50ml sterile saline or Ringers Solution for five minutes and repeated twice.
The graft was then transferred to the recipient bed with the basement membrane side facing up and connective tissue on the periosteum.
The allograft was trimmed to cover the defect dimensions up to the implant-abutment interface.
There was a 4mm margin added to the width on each side to account for lateral contraction as with the connective tissue.
With sterile moist gauze, pressure was applied to the graft for proper adaptation to the wound bed.
The graft was sutured with a single sling and the flap with a double sling.
Simple interrupted sutures were used to close vertical releases.
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All patients were treated with infiltration of local anesthetic with vasoconstrictor if noted tolerable by the medical history. Surgeons were then notified if the patient was randomized to the test or control according to a blinded treatment assignment. In both groups, anesthesia was confirmed at the implant site and the palatal donor site if indicated. The recipient bed was then prepared. Vertical incisions were made at the defect at line angles and horizontal incisions connected the two vertical releases intrasulcularly without involving the interdental papilla. The flap was reflected as a full thickness flap maintaining the integrity of the collagen attachment with de-epithelialization of papilla to allow for coronal advancement. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Recession Correction
大体时间:6 Months
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Change in recession was recorded at baseline, 6 weeks, 3 months and 6 months after grafting.
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6 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Concavity Correction
大体时间:6 Months
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At baseline, 6 weeks, 3 months, and 6 months after grafting, buccal concavities were measured.
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6 Months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Tissue Thickness
大体时间:6 Months
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Tissue thickness was measured with a 25 endodontic file with rubber stopper at baseline, 6 weeks, 3 months and 6 months after grafting.
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6 Months
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Implant Esthetics
大体时间:6 Months
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Implant esthetics were rated with written survey by both the subject and clinician.
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6 Months
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Psychosocial Data
大体时间:6 months
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Subjects completed questionnaires regarding their quality of life during the study by written survey.
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6 months
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合作者和调查者
调查人员
- 学习椅:Hom-Lay Wang, DDS, MS, PhD、University of Michigan
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- UM-Anderson-10
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