Apically Positioned Flap vs Rolled Flap for Soft Tissue Management During Implant Second-Stage Surgery
Peri-Implant Soft Tissue Management During Second-Stage Surgery With Two Different Flap Techniques: A Randomized Controlled Study
Patients are being asked to consider joining a research study that looks at two different ways dentists uncover dental implants during a small gum surgery. To join this study, Patients must have two dental implants that are ready to be uncovered. Both uncovering methods used in this research are normal, safe procedures that dentists already use every day. The purpose of this study is to learn which method helps the gums heal better, stay thicker, and look more natural over time.
If patients decide to participate, the dentist will use one method on one implant and the other method on the second implant so we can compare how each implant heals. The study lasts about one year and includes the uncovering surgery plus scheduled follow-up visits. At these visits, the dentist will gently measure your gums, take pictures, take routine dental X-rays, and use a small camera scanner to check how the gum tissue changes. Patients will also be asked to rate any pain or swelling after surgery.
Patients may have soreness, swelling, or minor bleeding-these are the same risks patients would have during normal implant care. Patients may or may not personally benefit, but the extra monitoring may help us track the healing closely, and patients' participation can help dentists improve care for future patients.
Patients can receive regular implant treatment without joining the study. The goal of this summary is to help you think about the pros and cons and decide what feels right for patients.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Olivia Bodnar, DDS
- 电话号码：6142924641
- 邮箱：bodnar.61@buckeyemail.osu.edu
研究联系人备份
- 姓名：Guo-Liang Cheng, DDS, MS
- 电话号码：6142924641
- 邮箱：cheng.712@osu.edu
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients between the ages of 18-80.
- Non-smokers or former smokers with at least a 5-year successful cessation history.
- Patients with normal systemic health (ASA-I) or well-controlled/stable systemic conditions (ASA-II), such as diabetes with HbA1c < 7.0%, no recent acute myocardial infarction or cerebrovascular accidents within 6 months, or any contraindication for periodontal or implant surgery.
- Patients who had, or plan to have, 2 non-adjacent implants of the same system placed under a two-stage implant protocol.
- The diameter discrepancy of the 2 target implants must be less than 1 mm.
Exclusion Criteria:
- Current smokers, or smokers who have quit <5 years prior to study entry.
- Pregnant or lactating women
- Patients with substance or alcohol abuse
- Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
- Other systemic conditions or medication affecting wound healing.
- Poor plaque control with plaque score > 20%
- Active/untreated odontogenic and periodontal infections
- Implants placed, or planned to be placed, with one-stage implant protocol.
- The diameter discrepancy of the 2 target implants is equal to or greater than 1 mm (≥ 1 mm).
- Implants showing signs of early peri-implant bone loss or infection.
- Severe loss of keratinized tissue (> 50%) at the implant site
- Non-English speaking individuals for studies involving informed consent.
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Apically Positioned Flap (APF)
During implant second-stage surgery, a crestal incision with vertical releases is used to elevate a flap that is repositioned apically and buccally to increase the width of keratinized tissue around the implant, followed by placement of a healing abutment and suturing.
|
A flap design used during implant second-stage surgery in which a crestal incision with vertical releases is performed, and the flap is repositioned apically and buccally to increase the width of keratinized tissue around the implant.
|
|
实验性的：Rolled Flap Technique (RFT)
During implant second-stage surgery, a full-thickness flap is elevated, and a pedicled connective tissue portion is de-epithelialized and rolled toward the buccal aspect to increase peri-implant soft tissue thickness, followed by placement of a healing abutment and suturing.
|
A flap design used during implant second-stage surgery in which a pedicled connective tissue portion of the flap is de-epithelialized and rolled toward the buccal aspect to increase peri-implant soft tissue thickness.
|
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 |
|---|---|---|
|
Change in Keratinized Tissue Width
大体时间：Baseline (second-stage surgery) to 12 months after surgery
|
Keratinized tissue width will be measured clinically in millimeters at the mid-buccal aspect of the implant using a periodontal probe at prespecified follow-up visits.
|
Baseline (second-stage surgery) to 12 months after surgery
|
|
Change in Peri-Implant Mucosal Thickness
大体时间：Baseline (second-stage surgery) to 12 months after surgery
|
Peri-implant mucosal thickness will be assessed by superimposing serial intraoral scan data to quantify changes in buccal soft tissue thickness at implant sites over time.
|
Baseline (second-stage surgery) to 12 months after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pink Esthetic Score (PES)
大体时间：3, 6, and 12 months after second-stage surgery
|
Peri-implant soft tissue esthetics will be evaluated using the Pink Esthetic Score based on standardized clinical photographs, assessing papilla, tissue contour, color, and texture.
|
3, 6, and 12 months after second-stage surgery
|
|
Change in Peri-Implant Soft Tissue Volume
大体时间：Baseline to 3, 6, and 12 months after second-stage surgery
|
Three-dimensional soft tissue volume changes will be quantified by superimposing serial intraoral scan data obtained at baseline and follow-up visits.
|
Baseline to 3, 6, and 12 months after second-stage surgery
|
|
Early Wound Healing Index
大体时间：1 and 2 weeks after second-stage surgery
|
Early wound healing will be assessed using a standardized healing index based on tissue color, bleeding, granulation tissue, and epithelialization.
|
1 and 2 weeks after second-stage surgery
|
|
Plaque Index (PI)
大体时间：1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
Oral hygiene status will be assessed using the plaque index based on clinical examination at peri-implant sites.
|
1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
|
Modified Sulcular Bleeding Index (mSBI)
大体时间：1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
Peri-implant soft tissue inflammation will be assessed using the modified sulcular bleeding index during clinical examination.
|
1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
|
Postoperative Pain Score
大体时间：1 and 2 weeks after second-stage surgery
|
Participant-reported pain will be measured using a visual analog scale (VAS, 0-100), where higher scores indicate greater pain intensity.
|
1 and 2 weeks after second-stage surgery
|
|
Postoperative Swelling Score
大体时间：1 and 2 weeks after second-stage surgery
|
Participant-reported swelling will be assessed using a visual analog scale (VAS, 0-100), where higher scores indicate greater perceived swelling.
|
1 and 2 weeks after second-stage surgery
|
|
Change in Peri-Implant Bone Level
大体时间：Baseline to 12 months after second-stage surgery
|
Peri-implant marginal bone levels will be assessed using standardized periapical radiographs and compared between baseline and follow-up.
|
Baseline to 12 months after second-stage surgery
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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
- STUDY20252723
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.