Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT) (RCT)
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel: A Randomized Controlled Study
Thirty children with recurrent apthous ulcer will be divided into 3 groups of different treatment modalities to assess their effect on pain, ulcer size, healing and postoperative pain
研究概览
详细说明
Enrolled children will be randomly allocated to three groups of ten individuals each:
Group one: patients will receive laser therapy with diode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact.
Group two: patients will use hyaluronic acid (Gengigel gel) 4 times daily. Group three: patients will receive oral hygiene instructions by avoiding spicy food, cold and hot drinks (control group).
Recruitment of subjects Patients with clinically diagnosed RAS of both sexes with age range between 10-14 years old will be selected from the outpatient clinics of the National Research Centre.
Assessment:
A) Assessment of the pain related to the ulcer:
A visual analogue scale (VAS) will be used consisting of a 10-cm horizontal line starting with a pole of no pain to reach the end pole presenting the unbearable pain. Individuals will be requested to mark the point on the horizontal line that best signifies their pain level (Greenberg et al., 2003).
B) Assessment of the ulcer sizes:
The ulcer size will be measured by a calibrated periodontal probe, the two dimensions will be calculated to represent the cross-sectional areas of the lesion (Legeret and Furlano, 2021).p13
C) Assessment healing by the effectiveness indices (EI) of healing:
The effectiveness indices (EI) of the pain improvement and ulcer size will be analyzed with a formula EI = [(V1 - V4 or V6) ÷ V1] × 100 %] where V4 and V6 referrs to the values which will be measured at day 4 visit and day 6 visit, while V1 referred to the baseline value.
The effectiveness indices will be evaluated on a 4-Rank scale: (Liu et al., 2006).
- Rank (1): Heal: EI ≥ 95%.
- Rank (2): Marked improvement: El < 95%, but ≥ 70%.
- Rank (3): Moderate improvement: EI < 70%, but ≥ 30%.
- Rank (4): No improvement: EI < 30%.
D) Assessment of postoperative pain:
A survey questionnaire with ordinal scales will be filled by asking the children at each visit concerning their subjective experience of eating, drinking, and brushing teeth. there will be 4 response alternatives (no, slight, moderate, and severe difficulties)
研究类型
注册 (估计的)
阶段
- 不适用
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:
- Children should be willing to participate in the study.
- Children should have a history of recurrent apthous stomatitis for at least two years with a frequency of at least one outbreak every two months
- Each ulcer had well defined margin for a period less than two days in child complained from pain.
- Each ulcer was in applicable area for easy management.
Exclusion Criteria:
- Patients had history of using topical or systemic medication for management of recurrent apthous stomatitis, such as corticosteroid therapy, antibiotics or analgesics during the previous month.
- Patient with special syndrome & immunological disease where RAS is one of its clinical presentations.
- Patient with allergic conditions
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：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：laser therapy
diode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact. |
Diode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact. |
|
实验性的：Hyaluronic acid group
Hyaluronic acid (Gengigel gel) 4 times daily. |
Hyaluronic acid (Gengigel gel) 4 times daily. |
|
实验性的：Negative control group
Oral hygiene instructions by avoiding spicy food, cold and hot drinks (control group). |
oral hygiene instructions by avoiding spicy food, cold and hot drinks (control group). |
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 |
|---|---|---|
|
Severity of preoperative pain related to the ulcer
大体时间：2 weeks
|
Assessment of the pain related to the ulcer where the unit of measurement is numbers from zero to ten. The measurement tool will be A visual analogue scale (VAS) consisting of a 10-cm horizontal line starting with a pole of no pain (zero) to reach the end pole presenting the unbearable pain (ten). Individuals will be requested to mark the point on the horizontal line that best signifies their pain level |
2 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of ulcer size reduction
大体时间：2 weeks
|
The measurement tool will be the measurement of ulcer size by a calibrated periodontal probe, the two dimensions will be calculated to represent the cross-sectional areas of the lesion, The unit of measurement is millimeter where decreasing in ulcer size represent favorable healing |
2 weeks
|
|
Rate of effectiveness indices (EI) of healing
大体时间：2 weeks
|
The measurement tool will be the effectiveness indices (EI) of the pain improvement and ulcer size will be analyzed with a formula EI = [(V1 - V4 or V6) ÷ V1] × 100 %] where V4 and V6 refers to the values which will be measured at day 4 visit and day 6 visit, while V1 referred to the baseline value. The effectiveness indices will be evaluated on a 4-Rank scale: (Liu et al., 2006).
|
2 weeks
|
|
Rate of postoperative complications
大体时间：2 weeks
|
The measurement tool will be survey questionnaire with ordinal scales will be filled by asking the children at each visit concerning their subjective experience of eating, drinking, and brushing teeth. The unit of measurement will be 4 response alternatives (no, slight, moderate, and severe difficulties) |
2 weeks
|
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
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
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