The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Mucosal Thickness
研究概览
简要总结
Scientists do research to answer important questions which might help change or improve the way we do things in the future.
The investigators know that using Enamel Matrix Derivatives results in thicker gum tissues around teeth. This study will test to see if using EMD around implants results in thicker gum tissues around implants.
详细描述
The hypothesis of the study is that the addition of EMD under the gingival flap prior to suturing will result in increased mucosal tissue thickness and increased keratinized tissue width as compared to not using the EMD.
The EMD will be deposited under the mucosal flap during the second stage implant uncovering. After flap suturing, an intraoral scan will be obtained. This procedure will require approximately 5 - 10 minutes per patient. All patients will be followed up at 14 days for suture removal per standard of care and not as part of the study. All patients will be followed up at one and three months per standard of care during which visits they will undergo an intraoral scan to allow evaluation of soft tissue dimensions. This is research only procedure that is expected to add 5 - 10 minutes to the regular postoperative visit. Study participation will be completed at the 3-month visit.
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
- Single (Participant)
盲法说明
Prior to the beginning of the surgical procedure, the PI will request that a faculty member not involved in the case randomly select a sealed envelope and hand it to the resident completing the procedure. The surgeon will not be blinded as it is not possible since only the experimental group will only receive the EMD.The patients will be blinded as to which group they are randomized into.
入排标准
- 年龄范围
- 18 Years 至 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability of subject to understand and the willingness to sign a written informed consent document.
- •Males and females; Age 18 to 89 years old
- •Require second stage implant uncovering
- •In either the maxillary or mandibular arch
- •Has consistent transportation for all clinical and study visits
排除标准
- •Pregnancy, or those planning to become pregnant
- •Allergy or any medical issue using EMD
- •Non-English speaking
- •Patients on anticoagulants
- •Patients who object to the use of animal products
研究组 & 干预措施
Group 1: Experimental Group using EMD
During implant uncovering the experimental group will receive EMD under the buccal flap
干预措施: Enamel Matrix Derivative (Device)
Group 2: Control Group
No EMD is administered under the buccal flap during suturing
结局指标
主要结局
Mucosal Thickness
时间窗: One month and 3 months
Mucosal thickness at 1 and 5mm below the free gingival margin will be measured
Change in Keratinized mucosal width
时间窗: One month and 3 months
measurement of keratinized mucosal width at one and three months after surgical uncovering of the dental implant
次要结局
未报告次要终点
研究者
Angela Palaiologou-Gallis, DDS, MS
Professor
The University of Texas Health Science Center at San Antonio