Effect of Zinc Oxide Ointment on Recurrent Aphthous Stomatitis (ZO-RAS)
2026年4月29日 更新者：Esraa hamdy、Faculty of Dental Medicine for Girls
Evaluation of Zinc Oxide Ointment in Treatment of Recurrent Aphthous Stomatitis
This randomized placebo-controlled trial evaluated the effectiveness of zinc oxide ointment in the treatment of recurrent aphthous stomatitis (RAS).
The study included 100 patients randomly assigned to receive either zinc oxide ointment or a placebo, applied three times daily for six days.
Pain intensity was measured using a visual analogue scale (VAS), and oral health-related quality of life was assessed using OHIP-14 at baseline and on days 1, 3, and 6.
研究概览
详细说明
This randomized, placebo-controlled clinical trial investigated the efficacy of topical zinc oxide ointment in the management of recurrent aphthous stomatitis (RAS). A total of 100 participants diagnosed with RAS were enrolled and randomly assigned in equal proportions to either the intervention group receiving zinc oxide ointment or the control group receiving a placebo formulation. The study medication was applied topically three times daily for a duration of six consecutive days.
Clinical outcomes were assessed at baseline and on days 1, 3, and 6 post-treatment initiation. Pain intensity was evaluated using a visual analogue scale (VAS), while oral health-related quality of life was measured using the Oral Health Impact Profile (OHIP-14). Additional clinical observation included assessment of ulcer size and surrounding erythematous halo.
研究类型
介入性
注册 (实际的)
100
阶段
- 第四阶段
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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Cairo Governorate
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Cairo、Cairo Governorate、埃及、11651
- Faculty of Dental Medicine for Girls ,Al-Azhar university
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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
接受健康志愿者
不
描述
Inclusion Criteria:
- -Systemically healthy subjects suffering from minor oral RAS.
- Patients of both sexes, aged 16-45 years (to avoid the potential effects of age on healing).
- Participants had not received any treatment for the ulcers before being included in the study and had no active periodontitis.
- Ulcers are of a duration of less than 48 hours.
Exclusion Criteria:
- -Participants with removable prosthetic or orthodontic appliances (to avoid potential effects on healing).
- Tobacco chewers, smokers or alcoholics.
- Pregnant or lactating females.
- Patients who had previously or are presently taking medications that could affect events associated with the healing process (erg, corticosteroids, oral antidiabetics, non-steroidal anti-inflammatory drugs, immune-modulating agents).
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Znic Oxide Ointment group
Participants administrated Zinc Oxide Ointment 3 times for 7days.
Participants instructed to apply ointment after drinking and eating.
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zinc oxide ointment that was formulated as in a polyethylene glycol base.
The prepared ointment was evaluated for organoleptic properties such as odor, color, pH, smoothness, and spread ability
其他名称：
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安慰剂比较：Placebo
Placebo ointment was administered by this group; it was prepared the same as the test ointment, without zinc oxide.
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A topical placebo ointment that was prepared the same as the test ointment without zinc oxide.
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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Visual analog scale
大体时间：Before treatment ,Day 1,Day 3 and Day 6
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A Visual Analog Scale (VAS) is a subjective, validated, 100mm (or 10cm) straight-line tool used in healthcare to measure pain intensity, fatigue, or other sensations.
Patients mark their sensation level between "no pain" (0) and "worst pain imaginable" (100).
It is highly sensitive for tracking changes in symptoms over time
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Before treatment ,Day 1,Day 3 and Day 6
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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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Diameter of the ulcer
大体时间：Day before treatment,1st day,3rd day and 6th day
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Measurement of erythematous halo diameter and whitish base
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Day before treatment,1st day,3rd day and 6th day
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OHIP-14
大体时间：At day 6
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Oral health impact 14 questionnaire Secondary outcome: Oral health-related quality of life assessed using the validated Oral Health Impact Profile-14 (OHIP-14), with scores ranging from 0 to 56, where higher scores indicate poorer quality of life.
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At day 6
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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。
合作者
调查人员
- 首席研究员：Naglaa M. El-Wakeel, PhD、Al Azhar University for girls
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- El-Wakeel NM, Dawoud MHS. Topical insulin-liposomal formulation in management of recurrent aphthous ulcers: A randomized placebo-controlled trial. J Investig Clin Dent. 2019 Nov;10(4):e12437. doi: 10.1111/jicd.12437. Epub 2019 Jul 27.
- Ghorbani A, Akbari J, Boorboor M, Nekoukar Z, Eslami G. Evaluation of zinc sulfate mucoadhesive formulation on recurrent aphthous stomatitis: a randomized double-blind, placebo-controlled clinical trial. BMC Oral Health. 2020 Jul 28;20(1):212. doi: 10.1186/s12903-020-01194-4.
- Halboub E, Al-Maweri SA, Parveen S, Al-Wesabi M, Al-Sharani HM, Al-Sharani A, Al-Kamel A, Albashari A, Shamala A. Zinc supplementation for prevention and management of recurrent aphthous stomatitis: a systematic review. J Trace Elem Med Biol. 2021 Dec;68:126811. doi: 10.1016/j.jtemb.2021.126811. Epub 2021 Jun 12.
- Estornut C, Rinaldi G, Carceller MC, Estornut S, Perez-Leal M. Systemic and local effect of oxidative stress on recurrent aphthous stomatitis: systematic review. J Mol Med (Berl). 2024 Apr;102(4):453-463. doi: 10.1007/s00109-024-02434-8. Epub 2024 Feb 20.
- Parssinen M, Jasberg H, Mikkonen JJW, Kullaa AM. Oral mucosal pellicle as an immune protection against micro-organisms in patients with recurrent aphthous stomatitis: A hypothesis. Med Hypotheses. 2021 Jan;146:110449. doi: 10.1016/j.mehy.2020.110449. Epub 2020 Dec 11.
- Al-Maweri SA, Halboub E, Al-Sharani HM, Shamala A, Al-Kamel A, Al-Wesabi M, Albashari A, Al-Sharani A, Abdulrab S. Association between serum zinc levels and recurrent aphthous stomatitis: a meta-analysis with trial sequential analysis. Clin Oral Investig. 2021 Feb;25(2):407-415. doi: 10.1007/s00784-020-03704-8. Epub 2021 Jan 6.
- Kounoupis V, Andreadis D, Georgaki M, Albanidou-Farmaki E, Daniilidis M, Markopoulos A, Karyotis N, Nikitakis NG, Poulopoulos A. IL-10 and TGF-beta1 gene polymorphisms in Greek patients with recurrent aphthous stomatitis. Med Oral Patol Oral Cir Bucal. 2022 Sep 1;27(5):e426-e433. doi: 10.4317/medoral.25352.
- Silva TM, Bolzan TCA, Zanini MS, Alencar T, Rodrigues WD, Bastos KA, Severi JA, Resende JA, Villanova JCO. Development and Evaluation of a Novel Oral Mucoadhesive Ointment Containing Pomegranate Peel Extract as an Adjuvant for Oral Hygiene of Dogs. J Vet Dent. 2020 Sep;37(3):133-140. doi: 10.1177/0898756420973470. Epub 2020 Nov 25.
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)
2025年6月30日
初级完成 (实际的)
2026年1月30日
研究完成 (实际的)
2026年3月30日
研究注册日期
首次提交
2026年4月22日
首先提交符合 QC 标准的
2026年4月29日
首次发布 (实际的)
2026年5月4日
研究记录更新
最后更新发布 (实际的)
2026年5月4日
上次提交的符合 QC 标准的更新
2026年4月29日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- OMDR_105_1q
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
This study investigated whether zinc oxide (ZnO) ointment can help reduce pain and improve healing in patients with recurrent aphthous ulcers (mouth ulcers).
One hundred participants were divided into two groups: one received ZnO ointment and the other received a placebo.
The treatment was applied three times daily for six days.
Pain levels and oral health impact were measured before and after treatment.
The results showed that ZnO ointment helped reduce pain faster in the early days compared to placebo, but there was no significant difference in overall quality of life after six days.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.