Effect of Low-Level Laser on Pain and Healing of Donor Site Following Free Gingival Graft
2016年9月6日 更新者：Neda Moslemi、Tehran University of Medical Sciences
The Effect of Low-Level Laser Therapy on Patient's Pain and Healing of Palatal Donor Site Following Free Gingival Graft: A Randomized Controlled Clinical Trial
The aim of this randomized split-mouth design clinical trial is to clinically evaluate the effectiveness of diode laser in the healing of donor site of palate in free gingival graft.
研究概览
详细说明
Free gingival graft is the most predictable and successful method for increasing the width of keratinized tissue around teeth/dental implants and vestibular deepening.
However, patient discomfort during the healing time is a major disadvantage of this procedure.
Several methods have been introduced to accelerate the healing time and reduction of patient's pain during first days after surgery.
Low-level lasers have shown promising results in biostimulation of cell growth and differentiation in cultures.
However, there are lack of well designed double blind placebo controlled randomized controlled clinical studies evaluating the effects of Low-level laser therapy in acceleration of wound healing and pain relief of patients undergoing free gingival grafts.
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段2
- 第三阶段
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。
学习地点
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-
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Tehran、伊朗伊斯兰共和国
- Neda Moslemi
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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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- lack of keratinized tissue around teeth (bilateral)
Exclusion Criteria:
- patients with systemic diseases
- non-cooperative patients
- smokers
- poor oral hygiene
- root surface restorations or active caries
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：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：low-level laser therapy
Low-level laser (Diode, 66o nanometer, power:200 milli Watt (mW), Continuous wave, time of irradiation:32 seconds)is irradiated in donor site
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Low-level laser therapy with the following parameters: Wavelength:660 nanometer, power: 200 mW, continuous mode, tme of irradiation: 32 seconds
其他名称：
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安慰剂比较：Turned-off laser
The same protocol is applied in te donor site, unless the laser is remained off.
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Laser device is turned-off.
All parameters are like experimental group, however the laser in turned-off.
其他名称：
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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 |
|---|---|---|
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degree of epithelialization
大体时间：At day 7
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3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling
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At day 7
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degree of epithelialization
大体时间：At day 14
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3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling
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At day 14
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degree of epithelialization
大体时间：At day 21
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3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling
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At day 21
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Visual analogue scale (VAS) pain score
大体时间：at day 1
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ask from patient about numbers of tablet consumption,record VAS analysis
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at day 1
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Visual analogue scale (VAS) pain score
大体时间：at day 2
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ask from patient about numbers of tablet consumption,record VAS analysis
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at day 2
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Visual analogue scale (VAS) pain score
大体时间：at day 3
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ask from patient about numbers of tablet consumption,record VAS analysis
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at day 3
|
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Visual analogue scale (VAS) pain score
大体时间：at day 4
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ask from patient about numbers of tablet consumption,record VAS analysis
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at day 4
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Visual analogue scale (VAS) pain score
大体时间：at day 5
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ask from patient about numbers of tablet consumption,record VAS analysis
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at day 5
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Visual analogue scale (VAS) pain score
大体时间：at day 6
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ask from patient about numbers of tablet consumption,record VAS analysis
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at day 6
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Visual analogue scale (VAS) pain score
大体时间：at day 7
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ask from patient about numbers of tablet consumption,record VAS analysis
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at day 7
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Visual analogue scale (VAS) pain score
大体时间：at day 14
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ask from patient about numbers of tablet consumption,record VAS analysis
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at day 14
|
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Clinical healing
大体时间：at day 1
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Photographs were taken from donor and recipient sites.
Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
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at day 1
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Clinical healing
大体时间：at day 2
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Photographs were taken from donor and recipient sites.
Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
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at day 2
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Clinical healing
大体时间：at day 7
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Photographs were taken from donor and recipient sites.
Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
|
at day 7
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|
Clinical healing
大体时间：at day 14
|
Photographs were taken from donor and recipient sites.
Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
|
at day 14
|
|
Clinical healing
大体时间：at day 21
|
Photographs were taken from donor and recipient sites.
Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
|
at day 21
|
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：Neda Moslemi、Laser Research Center of Dentistry, Tehran University of Medical Sciences
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
2012年2月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年11月1日
研究注册日期
首次提交
2012年12月15日
首先提交符合 QC 标准的
2016年9月6日
首次发布 (估计)
2016年9月12日
研究记录更新
最后更新发布 (估计)
2016年9月12日
上次提交的符合 QC 标准的更新
2016年9月6日
最后验证
2016年9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.