Evaluation of Zinc Oxide Ointment in Treatment of Recurrent Aphthous Stomatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual analog scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-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.
排除标准
- •-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).
研究组 & 干预措施
Znic Oxide Ointment group
Participants administrated Zinc Oxide Ointment 3 times for 7days. Participants instructed to apply ointment after drinking and eating.
干预措施: zinc oxide (Drug)
Placebo
Placebo ointment was administered by this group; it was prepared the same as the test ointment, without zinc oxide.
干预措施: Placabo (Drug)
结局指标
主要结局
Visual analog scale
时间窗: Before treatment ,Day 1,Day 3 and Day 6
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
次要结局
- Diameter of the ulcer(Day before treatment,1st day,3rd day and 6th day)
- OHIP-14(At day 6)
研究者
Esraa hamdy
Dental student
Faculty of Dental Medicine for Girls