Evaluation of Multilayered PRF in Comparison With Connective Tissue Graft by Sohn Poncho's Technique on Peri-implant Mucosal Enhancement in the Esthetic Zone
2026年6月12日 更新者：Gulf Medical University
Evaluation of Multilayered PRF in Comparison With Connective Tissue Graft by Sohn Poncho's Technique on Peri-implant Mucosal Enhancement in the Esthetic Zone. A Randomized Clinical Trial
An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.PRF membrane and CTG has been utilized to improve peri-implant soft tissue thickness and increase the width of keratinized tissue around dental implants.
The stability of the PRF membrane is maintained by securing it with the healing abutment of the implant.
While a few longitudinal studies have assessed the benefits of using PRF membrane with Sohn's Poncho technique in the posterior region, its effectiveness in the anterior region of the mouth remains to be evaluated.
研究概览
地位
招聘中
详细说明
An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.13,
14 Recent studies have shown that the multilayering of the PRF membrane around implants have the same effect on peri-implant mucosal thickness in comparison to the gold standard which is the connective tissue graft without further patient morbidity 13, 14.
PRF membrane and CTG has been utilized to improve peri-implant soft tissue thickness and increase the width of keratinized tissue around dental implants.
The stability of the PRF membrane is maintained by securing it with the healing abutment of the implant.
While a few longitudinal studies have assessed the benefits of using PRF membrane with Sohn's Poncho technique in the posterior region, its effectiveness in the anterior region of the mouth remains to be evaluated.7,
8 Additionally, the stabilized PRF membrane ensures prolonged exposure of the wound site to bioactive growth factors.
Given these advantages, the potential benefits of using PRF membrane with dental implants in the anterior region need further exploration.
Thus, this study focuses on comparing multilayering PRF membrane with the gold standard which is the CTG in healing period of 2nd stage implant surgery.
研究类型
介入性
注册 (估计的)
26
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Nesma Shemais, PhD
- 电话号码：0529961988
- 邮箱：dr.nesma@gmu.ac.ae
学习地点
-
-
Ajman Emirate
-
Ajman、Ajman Emirate、阿拉伯联合酋长国、00000
- 招聘中
- Gulf Medical University
-
接触：
- Nesma Shemais
- 电话号码：0529961988
- 邮箱：dr.nesma@gmu.ac.ae
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
-Inclusion Criteria: Patients with single bounded missing tooth in the esthetic zone Patients in the age group of 21-65 years Patients having good oral hygiene (mean plaque score of < 25%) and with stable periodontal status.
-Exclusion Criteria: Smokers patients Patients with poor maintenance of oral hygiene, as determined by a mean plaque score of ≥ 25% despite efforts by the clinician to improve oral hygiene maintenance.
Patients with medically compromised conditions like uncontrolled diabetes mellitus or any systemic diseases that may result in compromised hard and soft tissue healing.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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 |
|---|---|
|
实验性的：Experimental: Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) is a second-generation au
The test group will be treated with dental implant + multilayered PRF membrane.
In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site.
A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone.
The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position.
For the purposes of standardization, implants will be placed at subcrestal level in both the groups.
In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment.
Simple interrupted sutures will be used to approximate the tissues.
|
The test group will be treated with dental implant + multilayered PRF membrane.
In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site.
A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone.
The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position.
For the purposes of standardization, implants will be placed at subcrestal level in both the groups.
In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment.
Simple interrupted sutures will be used to approximate the tissues.
|
|
有源比较器：Active Comparator: Connective Tissue Graft gingival grafting surgery that is done to enhance soft ti
The test group will be treated with dental implant + multilayered PRF membrane.
In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site.
A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone.
The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position.
For the purposes of standardization, implants will be placed at subcrestal level in both the groups.
In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment.
Simple interrupted sutures will be used to approximate the tissues.
|
The test group will be treated with dental implant and CTG.
In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site.
A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone.
The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position.
For the purposes of standardization, implants will be placed at subcrestal level in both the groups.
In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment.
Simple interrupted sutures will be used to approximate the tissues.
|
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 |
|---|---|---|
|
Peri-implant soft tissue thickness
大体时间：Time Frame: 6 weeks and 3 and 6 months
|
Volumetric
|
Time Frame: 6 weeks and 3 and 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
width of the keratinized tissue around dental implants
大体时间：Time Frame: baseline, 3 and 6 months
|
Periodontal probe mm
|
Time Frame: baseline, 3 and 6 months
|
|
Marginal bone loss
大体时间：6 months
|
CBCT measurement
|
6 months
|
|
Postoperative patient satisfaction VAS 0-5
大体时间：baseline, 2 weeks, 6 months
|
VAS 0-5
|
baseline, 2 weeks, 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Nesma MF Shemais、Assistant professor of Periodontology
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月10日
初级完成 (估计的)
2027年1月10日
研究完成 (估计的)
2027年2月1日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月16日
研究记录更新
最后更新发布 (实际的)
2026年6月16日
上次提交的符合 QC 标准的更新
2026年6月12日
最后验证
2026年6月1日
更多信息
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.